# Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2018-10924 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** May 22, 2018 - **Citation:** 83 FR 23686 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-2017-M-5863, FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-2017-M-5969, FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-2017-M-6232, FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-2017-M-6550, FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-2017-M-6800, and FDA-2017-M-6896] 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) is publishing a list of premarket approval applications (PMAs) that have been approved. 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: httpss://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-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-2017-M-5863, FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-2017-M-5969, FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-2017-M-6232, FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-2017-M-6550, FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-2017-M-6800, and FDA-2017-M-6896 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. • 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.gpo.gov/fdsys/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. FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524. 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 placed on the internet. 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 during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the internet from July 1, 2017, through December 31, 2017. 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 Made Available From July 1, 2017, Through December 31, 2017 PMA No., Docket No. Applicant Trade name Approval date P160015, FDA-2017-M-3372 Zoll Medical Corporation AED Plus® and Fully Automatic AED Plus® 5/26/2017 P970003/S207, FDA-2017-M-3951 Cyberonics, Inc VNS Therapy System 6/23/2017 P150048, FDA-2017-M-3990 Edwards Lifesciences, LLC Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve 6/29/2017 P930016/S048, FDA-2017-M-4022 AMO Manufacturing USA, LLC STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System 6/30/2017 P130021/S033, FDA-2017-M-4271 Medtronic CoreValve LLC Medtronic CoreValve TM System, Medtronic CoreValve TM Evolut TM R System and Medtronic CoreValve TM Evolut TM PRO Systems 7/10/2017 P160049, FDA-2017-M-4498 Spectranetics Corp Stellarex 0.035″ OTW Drug-coated Angioplasty Balloon 7/26/2017 P170006, FDA-2017-M-4756 Medtronic, Inc Avalus TM Bioprosthesis 7/31/2017 P170005, FDA-2017-M-4757 Abbott Molecular, Inc Abbott RealTi m e IDH2 8/1/2017 P160042, FDA-2017-M-4711 Prollenium Medical Technologies, Inc Ravanesse Ultra 8/4/2017 P030017/S275, FDA-2017-M-4904 Boston Scientific Neuromodulation Corporation Precision TM Spinal Cord Stimulator System, Precision Spectra TM Spinal Cord Stimulator System, Precision TM Novi TM Spinal Cord Stimulator System, Precision TM Montage TM MRI Spinal Cord Stimulator System, Precision TM Montage TM Spinal Cord Stimulator System and Spectra WaveWriter TM Spinal Cord Stimulator System 8/11/2017 P160054, FDA-2017-M-5320 Thoratec Corporation HeartMate 3 TM Left Ventricular Assist System 8/23/2017 P140015/S020, FDA-2017-M-5262 Tandem Diabetes Care, Inc t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM 8/25/2017 P170003, FDA-2017-M-5334 Lutonix, Inc Lutonix® 035 Drug Coated Balloon PTA Catheter, Model 9010 8/25/2017 P170007, FDA-2017-M-5438 Bioventus LLC DUROLANE® 8/29/2017 P150025/S003, FDA-2017-M-5813 Dako North America, Inc PD-L1 IHC 28-8 pharmDx 9/15/2017 P150042, FDA-2017-M-5863 ZEUS Scientific, Inc ZEUS ELISA Parvovirus B19 IgM Test System 9/19/2017 P150045, FDA-2017-M-5864 ZEUS Scientific, Inc ZEUS ELISA Parvovirus B19 IgG Test System 9/19/2017 P170011, FDA-2017-M-5884 ABIOMED, Inc Impella RP® System 9/20/2017 P150013/S006, FDA-2017-M-5929 Dako North America, Inc PD-L1 IHC 22C3 pharmDx 9/22/2017 P160030, FDA-2017-M-5969 Abbott Diabetes Care, Inc Freestyle Libre Flash Glucose Monitoring System 9/27/2017 P100047/S090, FDA-2017-M-5968 Medtronic, Inc HeartWare TM HVAD TM System 9/27/2017 P100021/S063, FDA-2017-M-5997 Medtronic Vascular Endurant II/Endurant IIs Stent Graft System 9/29/2017 P160039, FDA-2017-M-6223 Respicardia, Inc remedē® System 10/6/2017 P170002, FDA-2017-M-6232 Teoxane S.A RHA® 2, RHA® 3 and RHA® 4 10/19/2017 P150028/S001, FDA-2017-M-6290 NuMED, Inc Cheatham Platinum (CP) Stent System (Covered CP Stent, Model 427; Covered Mounted (CP) Stent, Model 428; CP Stent, Model 425; Mounted CP Stent, Model 426) 10/24/2017 H020002/S046, FDA-2017-M-6524 Stryker Neurovascular Neuroform Atlas TM Stent System 11/2/2017 P160057, FDA-2017-M-6525 OrthogenRx, Inc TriVisc 11/13/2017 P160043/S001, FDA-2017-M-6550 Medtronic Vascular Resolute Onyx TM Zotarolimus-Eluting Coronary Stent System 11/16/2017 P160055, FDA-2017-M-6614 RxSight, Inc Light Adjustable Lens (LAL) and Light Delivery Device (LDD) 11/22/2017 P170008, FDA-2017-M-6650 Medinol Ltd EluNIR® Ridaforolimus Eluting Coronary Stent System 11/28/2017 P170019, FDA-2017-M-6799 Foundation Medicine, Inc FoundationOne CDx 11/30/2017 P150031, FDA-2017-M-6800 Boston Scientific Corporation Vercise Deep Brain Stimulation (DBS) System 12/8/2017 P170012, FDA-2017-M-6896 Biom'Up SA HEMOBLAST TM Bellows 12/15/2017 II. Electronic Access Persons with access to the internet may obtain the documents at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm . Dated: May 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10924 Filed 5-21-18; 8:45 am] BILLING CODE 4164-01-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2018-10924. Public record. Not legal advice.