Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Federal RegisterMar 24, 2021
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-2018-M-4033, FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-M-2522, FDA-2019-M-2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-2019-M-2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-2019-M-3652, FDA-2019-M-3845, FDA-2019-M-3863, FDA-2019-M-3844, FDA-2019-M-4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-4238, FDA-2019-M-4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-5438, FDA-2019-M-5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-5741, FDA-2019-M-5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-0107, FDA-2020-M-0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-0984, FDA-2020-M-0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-1116, FDA-2020-M-1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-1267, FDA-2020-M-1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-1300, FDA-2020-M-1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-1410, FDA-2020-M-1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-1600, FDA-2020-M-1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-1724, FDA-2020-M-1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-1760, FDA-2020-M-1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-1828, FDA-2020-M-1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-1838, FDA-2020-M-1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-2288, FDA-2020-M-2248, and FDA-2020-M-2339]
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved from October 1, 2018, through December 31, 2020. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.
ADDRESSES:
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
•
Federal eRulemaking Portal:
https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to
https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on
https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Written/Paper Submissions
Submit written/paper submissions as follows:
•
Mail/Hand Delivery/Courier (for written/paper submissions):
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions:
All submissions received must include the Docket Nos. FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-2018-M-4033, FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-
2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-2019-M-2522, FDA-2019-M-2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-2019-M-2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-2019-M-3652, FDA-M-3845, FDA-2019-M-3862, FDA-2019-M-3863, FDA-2019-M-3844, FDA-2019-M-4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-4238, FDA-2019-M-4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-5438, FDA-2019-M-5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-5741, FDA-2019-M-5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-0107, FDA-2020-M-0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-0984, FDA-2020-M-0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-1116, FDA-2020-M-1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-1267, FDA-2020-M-1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-1300, FDA-2020-M-1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-1410, FDA-2020-M-1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-1600, FDA-2020-M-1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-1724, FDA-2020-M-1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-1760, FDA-2020-M-1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-1828, FDA-2020-M-1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-1838, FDA-2020-M-1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-2288, FDA-2020-M-2248, and FDA-2020-M-2339 for “Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at
https://www.regulations.gov
or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket:
For access to the docket to read background documents or the electronic and written/paper comments received, go to
https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
Dharmesh Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-3289.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is published in the
Federal Register
. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision.
The regulations provide that FDA publish a list of available safety and effectiveness summaries of PMA approvals and denials that were announced. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the internet from October 1, 2018, through December 31, 2020. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date.
Table 1—List of Safety and Effectiveness Summaries for Approved PMAs and Safety and Probable Benefit Summaries for Approved HDEs Made Available From October 1, 2018, Through December 31, 2020
PMA No., Docket No.
Applicant
Trade name
Approval date
P180003, FDA-2018-M-3841
Veryan Medical Ltd
BioMimics 3D Vascular Stent System
10/4/2018
P150040/S003, FDA-2018-M-3842
Carl Zeiss Meditec, Inc
VisuMax Femtosecond Laser
10/4/2018
P160054/S008, FDA-2018-M-3983
Thoratec Corp
HeartMate 3 Left Ventricular Assist System
10/18/2018
P100040/S036, FDA-2018-M-4033
Medtronic Vascular
Valiant Navion
TM
Thoracic Stent Graft System
10/19/2018
P180010, FDA-2018-M-4205
W.L. Gore & Associates, Inc
GORE Carotid Stent
11/1/2018
P150002, FDA-2018-M-4580
Cordis Corp
Cordis INCRAFT® AAA Stent Graft System
11/27/2018
P120016/S024, FDA-2018-M-4582
Cardiva Medical, Inc
VASCADE® MVP Venous Vascular Closure System
11/27/2018
P180007, FDA-2018-M-4665
Spiration, Inc
Spiration® Valve System
12/3/2018
P160034, FDA-2018-M-4672
Cardiac Science Corp
Powerheart® G3 Pro AED
12/6/2018
P160033, FDA-2018-M-4675
Cardiac Science Corp
Powerheart® G5 AED, Powerheart® AED G3 Plus, And Powerheart® AED G3
12/7/2018
P160043/S012, FDA-2018-M-4777
Medtronic Vascular
Resolute Onyx
TM
Zotarolimus-Eluting Coronary Stent System
12/14/2018
P110013/S088, FDA-2018-M-4778
Medtronic Vascular
Resolute Integrity Zotarolimus-Eluting Coronary Stent System
12/14/2018
P100018/S015, FDA-2018-M-4779
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Pipeline
TM
Flex Embolization Device
12/14/2018
P150038/S006, FDA-2018-M-4780
InSightec, Inc
Exablate Model 4000 Types 1.0 and 1.1 System (Exablate Neuro)
12/16/2018
P170018, FDA-2018-M-4916
Physio-Control, Inc
LIFEPAK® CR2 Defibrillator
12/21/2018
P170032, FDA-2019-M-0027
Sequent Medical, Inc
Woven EndoBridge (WEB) Aneurysm Embolization System
12/31/2018
P180001, FDA-2019-M-0028
William Cook Europe ApS
Zenith® Dissection Endovascular System
12/31/2018
P170037, FDA-2019-M-0505
OPKO Diagnostics, LLC
Sangia Total PSA Test
1/30/2019
P180025, FDA-19M-2526
Essential Medical, Inc
MANTA
TM
Vascular Closure Device
2/1/2019
P170036, FDA-2019-M-0645
Spinal Kinetics LLC
M6-C
TM
Artificial Cervical Disc
2/6/2019
P160050, FDA-2019-M-0802
Intrinsic Therapeutics
Barricaid® Anular Closure Device (ACD)
2/8/2019
P170030, FDA-2019-M-0885
Biotronik, Inc
Orsiro Sirolimus Eluting Coronary Stent System (Orsiro Stent System)
2/22/2019
P170042/S002, FDA-2019-M-0995
C.R. Bard, Inc
COVERA
TM
Vascular Covered Stent
3/1/2019
P160002/S009, FDA-2019-M-1310
Ventana Medical System, Inc
VENTANA PD-L1 (SP142) Assay
3/8/2019
P180037, FDA-2019-M-1214
Bard Peripheral Vascular, Inc. (BPV)
VENOVO Venous Stent System
3/13/2019
P100009/S028, FDA-2019-M-1251
Abbott Vascular, Inc
MitraClip NT Clip Delivery System; MitraClip NTR/XTR Clip Delivery System
3/14/2019
P180036, FDA-2019-M-1313
Impulse Dynamics (USA), Inc
OPTIMIZER Smart System
3/21/2019
P180040, FDA-2019-M-1465
Fidia Pharma USA, Inc
TRILURON
TM
3/26/2019
P180032, FDA-2019-M-1506
Channel Medsystems, Inc
Cerene® Cryotherapy Device
3/28/2019
P170027, FDA-2019-M-1582
TherOx, Inc
TherOx DownStream System
4/2/2019
P180034, FDA-2019-M-1763
Intact Vascular, Inc
Tack Endovascular System® (6F)
4/11/2019
P180043, FDA-2019-M-1979
QIAGEN Manchester Ltd
therascreen
® FGFR RGQ RT-PCR Kit
4/12/2019
P180024, FDA-2019-M-1848
BAROnova, Inc
TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
4/16/2019
P180029, FDA-2019-M-1998
Boston Scientific Corp
LOTUS Edge
TM
Valve System
4/23/2019
P180014, FDA-2019-M-2052
XVIVO Perfusion, Inc
XVIVO Perfusion System (XPS
TM
) with STEEN Solution
TM
Perfusate
4/26/2019
P180013, FDA-2019-M-2193
Boston Scientific Corp
VICI VENOUS STENT® System
5/2/2019
P180031, FDA-2019-M-2408
Stryker Neurovascular
Neuroform Atlas® Stent System
5/16/2019
H180002, FDA-2019-M-2522
Novocure, Ltd
NovoTTF
TM
-100L System
5/23/2019
P190001, FDA-2019-M-2560
QIAGEN GmbH
therascreen
PIK3CA RGQ PCR Kit
5/24/2019
P190004, FDA-2019-M-2561
QIAGEN GmbH
therascreen
PIK3CA RGQ PCR Kit
5/24/2019
P160013/S002, FDA-2019-M-2671
TransMedics, Inc
Organ Care System (OCS
TM
) Lung System
5/31/2019
P160036, FDA-2019-M-2732
DT MedTech, LLC
Hintermann Series H3
TM
Total Ankle Replacement System
6/4/2019
P160048/S006, FDA-2019-M-2753
Senseonics, Inc
Eversense Continuous Glucose Monitoring System
6/6/2019
P160029, FDA-2019-M-2782
Philips Medical Systems, Inc
HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A)
6/6/2019
P150013/S014, FDA-2019-M-3309
Dako North America, Inc
PD-L1 IHC 22C3 pharmDx
6/10/2019
P000025/S104, FDA-2019-M-3513
MED-EL Corp
MED-EL Cochlear Implant System
7/19/2019
P150013/S016, FDA-2019-M-3652
Dako North America, Inc
PD-L1 1HC 22C3 pharmDx
7/30/2019
P140031/S085, FDA-2019-M-3845
Edwards Lifesciences LLC
Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System
8/16/2019
H190005, FDA-2019-M-3863
Zimmer Biomet Spine, Inc
The Tether
TM
—Vertebral Body Tethering System
8/16/2019
P180050, FDA-2019-M-3862
CVRx, Inc
BAROSTIM NEO® System
8/16/2019
P130021/S058, FDA-2019-M-3844
Medtronic CoreValve LLC
Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System
8/16/2019
H170001, FDA-2019-M-4007
ApiFix, Ltd
Minimally Invasive Deformity Correction (MID-C) System
8/23/19
P040020/S087, FDA-2019-M-4153
Alcon Laboratories, Inc
AcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50 and TFNT60)
8/26/2019
P190006, FDA-2019-M-4186
Axonics Modulation Technologies, Inc
Axonics Sacral Neuromodulation System
9/6/2019
P930016/S057, FDA-2019-M-4238
AMO Manufacturing USA, LLC
iDESIGN® Refractive Studio and STAR S4 IR® Excimer Laser Systems
9/9/2019
P190011, FDA-2019-M-4928
DiaSorin Inc
LIAISON XL MUREX HCV Ab LIAISON XL MUREX Control HCV Ab
10/18/2019
P190014, FDA-2019-M-4978
Myriad Genetic Laboratories, Inc
Myriad myChoice® CDx
10/23/2019
P180046, FDA-2019-M-5393
Axonics Modulation Technologies, Inc
Axonics Sacral Neuromodulation System
11/13/2019
P180035, FDA-2019-M-5438
CooperVision, Inc
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
11/15/2019
P190008, FDA-2019-M-5534
Medtronic, Inc
IN.PACT
TM
AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
11/21/2019
P190016, FDA-2019-M-5605
Tusker Medical, Inc
Tula® System
11/25/2019
P180047, FDA-2019-M-5683
DiaSorin, Inc
LIAISON QuantiFERON—TB Gold Plus, LIAISON Control QuantiFERON—TB Gold Plus and LIAISON QuantiFERON Software
11/26/2019
P170019/S006, FDA-2019-M-5741
Foundation Medicine, Inc
FoundationOne® CDx
12/3/2019
P170038, FDA-2019-M-5857
Abbott
CentriMag Circulatory Support System
12/6/2019
P180027, FDA-2019-M-5961
MicroVention, Inc
Flow Re-Direction Endoluminal Device (FRED®) System
12/16/2019
P140009/S039, FDA-2020-M-0097
Abbott Medical, Inc
Abbott Infinity
TM
DBS System
1/2/2020
P180038, FDA-2020-M-0107
DiaSorin, Inc
LIAISON® XL MUREX Anti-HBc, LIAISON® XL MUREX Control Anti-HBc
1/2/2020
P190018, FDA-2020-M-0108
Alcon Research, Inc
Clareon
TM
Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) (Model Number: SY60WF); Clareon
TM
Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) (Model Numbers: CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8 and CNW0T9); Clareon
TM
Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMe
TM
Pre-loaded Delivery System (Model Number: CNA0T0); Clareon
TM
Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMe
TM
Pre-loaded Delivery System (Model Numbers: CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8 and CNA0T9)
1/7/2020
P170023, FDA-2020-M-0495
Contura International A/S
Bulkamid® Urethral Bulking System
1/28/2020
P170022, FDA-2020-M-0985
ARJ Medical, Inc
PyloPlus UBT System
2/18/2020
P180039, FDA-2020-M-0984
DiaSorin Inc
LIAISON® XL MUREX Anti-HBs; LIAISON® XL MUREX Control Anti-HBs; LIAISON® XL MUREX Anti-HBs Verifiers
2/21/2020
P930014/S126, FDA-2020-M-0986
Alcon Laboratories, Inc
AcrySof
TM
IQ Vivity
TM
Extended Vision Intraocular Lens (Model DFT015); AcrySof
TM
IQ Vivity
TM
Toric Extended Vision IOLs (DFT315, DFT 415, DFT515); AcrySof
TM
IQ Vivity
TM
Extended Vision UV Absorbing IOL (DAT015); AcrySof
TM
IQ Vivity
TM
Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515)
2/26/2020
P190024, FDA-2020-M-1083
Ventana Medical Systems, Inc
CINtec®
PLUS
Cytology
3/10/2020
P120006/S031, FDA-2020-M-1126
Endologix, Inc
Alto
TM
Abdominal Stent Graft System
3/13/2020
P980033/S050, FDA-2020-M-1115
Boston Scientific Corp
VENOUS WALLSTENT
3/17/2020
P970051/S172, FDA-2020-M-1116
Cochlear Americas
Nucleus 24 Cochlear Implant System
3/17/2020
P190025, FDA-2020-M-1175
Abbott Molecular, Inc
Alinity m HCV
3/23/2020
P140029/S021, FDA-2020-M-1214
Q-Med AB, a Galderma affiliate
Restylane® Kysse
3/26/2020
P190028, FDA-2020-M-1213
Roche Molecular Systems, Inc
cobas HPV for use on the cobas 6800/8800 Systems
4/3/2020
P190027, FDA-2020-M-1286
Intact Vascular, Inc
Tack Endovascular System® (4F, 1.5-4.5mm)
4/10/2020
P050010/S020, FDA-2020-M-1267
Centinel Spine, LLC
prodisc® L Total Disc Replacement
4/10/2020
P130008/S039, FDA-2020-M-1299
Inspire Medical Systems, Inc
Inspire® Upper Airway Stimulation (UAS)
4/14/2020
P190026, FDA-2020-M-1290
QIAGEN GmbH
therascreen® BRAF V600E RGQ PCR Kit
4/15/2020
P170019/S013, FDA-2020-M-1300
Foundation Medicine, Inc
FoundationOne® CDx (F1CDx)
4/17/2020
P190015, FDA-2020-M-1311
Bolton Medical Inc
TREO® Abdominal Stent-Graft System
5/4/2020
P170019/S011, FDA-2020-M-1358
Foundation Medicine, Inc
FoundationOne® CDx (F1CDx)
5/6/2020
P160028, FDA-2020-M-1367
Philips Medical Systems, Inc
HeartStart FR3 Defibrillators Models 861388 (Text) and 861389 (ECG Display), Primary Battery (Models 989803150161, 989803150171), Rechargeable Battery (Model 989803150241), Charger for the Rechargeable Battery (Model 861394), SmartPads III (Models 989803149981, 989803149991), DP pads (Models 989803158211, 989803158221), and Pediatric Key (Model 989803150031)
5/11/2020
P180028, FDA-2020-M-1368
Philips Medical Systems, Inc
HeartStart FRx Defibrillator (861304), Primary Battery (M5070A), Aviation FRx Battery (989803139301), SMART Pads II (989803139261), and Infant/Child Key (989803139311)
5/11/2020
P150025/S013, FDA-2020-M-1410
Dako North America, Inc
PD-L1 IHC 28-8 pharmDx
5/15/2020
P170019/S015, FDA-2020-M-1420
Foundation Medicine, Inc
FoundationOne® CDx
5/19/2020
P110033/S047, FDA-2020-M-1527
Allergan
JUVÉDERM® VOLUMA
TM
XC
6/12/2020
P190021, FDA-2020-M-1583
Mainstay Medical Ltd
ReActiv8 Implantable Neurostimulation System
6/16/2020
P170019/S016, FDA-2020-M-1612
Foundation Medicine, Inc
FoundationOne® CDx (F1CDx)
6/16/2020
P200014, FDA-2020-M-1600
Roche Molecular Systems, Inc
cobas® EZH2 Mutation Test
6/18/2020
P100010/S098, FDA-2020-M-1613
Medtronic, Inc
Arctic Front Advance
TM
Cardiac Cryoablation Catheter Arctic Front Advance Pro
TM
Cardiac Cryoablation Catheters Freezor
TM
MAX
Cardiac Cryoablation Catheter CryoConsole Manual Retraction Kit
6/23/2020
P130013/S035, FDA-2020-M-1715
Boston Scientific Corp
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System
7/21/2020
P190031, FDA-2020-M-1724
Ventana Medical Systems, Inc
VENTANA HER2 Dual ISH DNA Probe Cocktail
7/28/2020
P180031/S001, FDA-2020-M-1726
Stryker Neurovascular
Neuroform Atlas® Stent System
7/30/2020
P200010, FDA-2020-M-1748
Guardant Health, Inc
Guardant360® CDx
8/7/2020
P190007, FDA-2020-M-1752
Cardinal Health
Kendall
TM
Multi-Function Defibrillation Electrodes, Medi-Trace
TM
Cadence Multi-Function Defibrillation Electrodes, Physio-Control/Stryker QUIK-COMBO Pacing/Defibrillation/ECG Electrodes
8/7/2020
P150003/S058, FDA-2020-M-1760
Boston Scientific Corp
SYNERGY
TM
Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail
TM
); SYNERGY
TM
Everolimus-Eluting Platinum Chromium Coronary Stent System (Over-The-Wire
TM
); SYNERGY
TM
XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail
TM
)
8/10/2020
P190032, FDA-2020-M-1821
Foundation Medicine, Inc
FoundationOne Liquid CDx
8/26/2020
P180048, FDA-2020-M-1783
Diasorin, Inc
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
8/29/2020
P180049, FDA-2020-M-1822
Diasorin, Inc
LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control Anti-HBe
8/29/2020
P180045, FDA-2020-M-1828
Diasorin, Inc
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
8/29/2020
P200013, FDA-2020-M-1830
Abbott Molecular, Inc
Alinity m HBV
8/29/2020
P190017, FDA-2020-M-1829
Diasorin, Inc
LIAISON® XL MUREX HBsAg Qual; LIAISON® MUREX Control HBsAg Qual; LIAISON® XL MUREX HBsAg Confirmatory Test
8/29/2020
P200015, FDA-2020-M-1835
Edwards Lifesciences, LLC
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
8/31/2020
P160017/S076, FDA-2020-M-1838
Medtronic Minimed, Inc
MiniMed 770G System
8/31/2020
P140031/S112, FDA-2020-M-1868
Edwards Lifesciences, LLC
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System
9/9/2020
P200022, FDA-2020-M-1986
Simplify Medical, Inc
Simplify® Cervical Artificial Disc
9/18/2020
P160042/S010, FDA-2020-M-2021
Prollenium Medical Technologies, Inc
Revanesse® Lips+
9/21/2020
H190001, FDA-2020-M-2248
HDL Therapeutics, Inc
Plasma Delipidation System (PDS-2
TM
System)
12/1/2020
P190030, FDA-2020-M-2288
Theragen, Inc
ActaStim-S Spine Fusion Stimulator
12/9/20
P200030, FDA-2020-M-2339
W. L. Gore and Associates, Inc
GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
12/22/20
II. Electronic Access
Persons with access to the internet may obtain the documents at
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: March 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06052 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.