Medical Devices; List of Premarket Approval Actions

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 98M-0136, 98M-0217, 98M-0138, 98M-0327, 98M-0328, 98M-

0219, 98M-0137, 98M-0404, 98M-0200, 98M-0140, 98M-0231, 98M-0187, 98M-

0139, 98M-0201, 98M-0403, 98M-0162, 97M-0084, 98M-0329, 98M-0450, 98M-

0451, 98M-0251, 98M-0507, 98M-0618, 98M-0604, 98M-0619, 96M-0678, 98M-

0679, 98M-0715, 98M-0711, and 98M-0725]

Medical Devices; List of Premarket Approval Actions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of

premarket approval application (PMA) approvals. This list is intended

to inform the public of the existence and the availability of summaries

of safety and effectiveness of approved PMA's through the Internet and

the agency's Dockets Management Branch.

ADDRESSES: Summaries of safety and effectiveness are available on the

World Wide Web (WWW) at http://www.fda.gov/cdrh/pma page.html. Copies

of summaries of safety and effectiveness are also available by

submitting a written request to the Dockets Management Branch (HFA-

305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852. Please cite the appropriate docket number as

listed in Table 1 in the SUPPLEMENTARY INFORMATION section of this

document, when submitting a written request.

FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ-402), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 30, 1998

(63 FR 4571), FDA published a final rule to revise Secs. 814.44(d) and

814.45(d) (21 CFR 814.44(d) and 814.45(d)) to discontinue publication

of individual PMA approvals and denials in the Federal Register.

Revised Secs. 814.44(d) and 814.45(d) state that FDA will notify the

public of PMA approvals and denials by posting them on FDA's home page

on the Internet (http://www.fda.gov), by placing the summaries of

safety and effectiveness on the Internet and in FDA's Dockets

Management Branch, and by publishing in the Federal Register after each

quarter a list of the PMA approvals and denials announced in that

quarter.

FDA believes that this procedure expedites public notification of

these actions because announcements can be placed on the Internet more

quickly than they can be published in the Federal Register, and FDA

believes that the Internet is accessible to more people than the

Federal Register.

In accordance with section 515(d)(3) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360e(d)(3)), 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 act. The 30-day period for requesting

reconsideration of an FDA action under Sec. 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

[[Page 71931]]

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 following is a list of all PMA applications for which summaries

of safety and effectiveness were placed on the Internet in accordance

with the procedure as explained previously through August 12, 1998.

There were no denial actions during this period. The list is in order

by PMA number and provides the manufacturer's name, the generic name or

trade name, and the approval date.

Table 1.--List of Approval PMA's From April 24, 1997, Through August 12, 1998

--------------------------------------------------------------------------------------------------------------------------------------------------------

PMA Number/Docket No. Applicant Trade Name Approval Date

--------------------------------------------------------------------------------------------------------------------------------------------------------

P940001/98M-0136 Gensia, Inc. Genesa (R) System September 12, 1997

P940015/98M-0217 Biomatrix, Inc. Synvisc (R) Hylan GF 20 August 8, 1997

P940016/98M-0138 B. Braun of America, Inc. Heparin-Induced September 19, 1997

Extracorporeal Precipitation

(H.E.L.P.) System

P940025/98M-0327 Lobob Laboratories Lobob R/RW Drop April 30, 1998

P940026/98M90328 Lobob Laboratories Rigid Gas Permeable Contact April 28, 1998

Lens Solution\1\ and Labob C/

D/S Cleaning Disinfecting

Storage Solution

P950031/98M-0219 Lobob Laboratories Lobob Cleaner April 3, 1998

P960036/98M-0137 Mentor Corp. Posterior Chamber Intraocular December 22, 1997

Lens

P960057/98M-0404 Gliatech, Inc. Inhibitor, Peridural May 27, 1998

Fibrosis\1\

P970002/98M-0200 Alliance Medical Monostrut Cardiac Value September 30, 1997

Technologies, Inc. Prosthesis\1\

P970003/98M-0140 Cyberonics, Inc. Neurocybernetic Prothesis July 16, 1997

System NE-LYJ Stimulator,

Autonomic Nerve, Implanted

for Epile

P970012/98M-0231 Medtronic, Inc. Medtronic, Kappa Pulse January 30, 1998

Generator\1\

P970017/98M-0187 Hologic, Inc. Acoustic Bone Densitometer March 12, 1998

Sahara Clinical Bone

Sonometer

P970021/98M-0139 Gynecare, Inc. Thermal Balloon Endometrial December 12, 1997

Ablation Thermachoice

Uterine Balloon Therapy

(UBT) System OB-MNB-Device,

Thermal Ablation,

Endometrial

P970038/98M-0201 Hybritech, Inc. Tandem Free PSA Assays\1\ March 10, 1998

P970044/98M-0403 Dornier Medical Systems, Inc. Transurethral Microwave May 29, 1998

Thermotherapy System,

Dornier Urowave

Thermotherapy System, GU-MEQ-

System, Hyperthermia, RF/

Microwave Benign Post

P970052/98M-0162 Cardiovascular Dynamics, Inc. Fact, Arc, Lynx, and Guardian February 20, 1998

Balloon Coronary Dilatation

Catheters Percutaneous

Transluminal Coronary

Angioplasty (PTCA) CV-LOX-

Catheters, Transluminal

Coronary Angioplasty, PE

P930016/S003/97M-0084 VISX, Inc. Excimer Laser for Ophthalmic April 24, 1997

Use

P930034/S009/98M-0329 Summit Technology, Inc. SVS APEX Plus Excimer Laser March 11, 1998

Workstation and Emphasis

Disc OP-LZS-LASER, System,

Excimer

[[Page 71932]]

P960013/98M-0450 Pacesetter, Inc. Tendril DX Models 1388 T/K June 20, 1997

Endocardial, Steroid Eluting

Screw-In Pacing Leads and

Ventritex Assure AFS Models

7010 T/K Endocardial Steroid

Eluting Screw In Pacing

Leads

P960042/98M-0451 Spectranetics Corp. 12 French Laser Sheath Kit December 9, 1997

P950009/S002/98M-0251 Neopath, Inc. Autopap Primary Screening May 5, 1998

System

P960013/98M-0450 St. Jude Medical Locator Steerable Stylet June 15, 1998

Model 4036

P960042/001/98M-0451 Spectranetics Corp. 12 French Outer Sheath June 16, 1998

P970062/98M-0507 BMT, Inc. Genestone 190 Lithotripter June 24, 1998

P970058/98M-0618 R2 Technology, Inc. M 1000 Image Checker June 26, 1998

P960011/98M-0604 Bio-Technology General Corp. Biolon 1% Sodium Hyaluronate July 16, 1998

Viscoelastic Surgical Aid

Fluid

P960018/98M-0619 Healthcare Products Plus, The Needlyzer The Needle July 16, 1998

Inc. Destroyer Model ND 2

P950005/98M-0678 Cordis Webster, Inc. Cordis Webster Diagnostic/ July 22, 1998

Ablation Deflectable Tip

Catheter

P980015/98M-0679 Biomedical Disposal, Inc. Sharpx Needle Destruction August 6, 1998

Unit

P970040/98M-0715 Lunar Achilles & Ultrasonometer June 26, 1998

P970051/98M-0711 Cochlear Corp. Nucleus 24 Cochlear Implant June 25, 1998

System

P960034/98M-0725 Pharmacia & UpJohn Cleon Heparin Surface August 12, 1998

Modified (ASM) Ultraviolet

light

--------------------------------------------------------------------------------------------------------------------------------------------------------

\1\ This means generic name.

Dated: December 15, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological Health.

[FR Doc. 98-34347 Filed 12-29-98; 8:45 am]

BILLING CODE 4160-01-F