[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