[Federal Register Volume 63, Number 250 (Wednesday, December 30, 1998)]
[Notices]
[Pages 71930-71932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34347]


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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.

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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
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                   PMA Number/Docket No.                               Applicant                      Trade Name                   Approval Date
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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
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\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