[Federal Register: December 15, 2000 (Volume 65, Number 242)]
[Notices]
[Page 78495-78496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de00-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 00M-1391, 00M-1536, 00M-1447, 00M-1522, 00M-0809, 00M-
1517, 00M-1451, 00M-1448, 00M-1507, 00M-1389, 00M-1388, 00M-1508, 00M-
1390, 00M-1386, 00M-1387, 00M-1414, 00M-1415, 00M-1416, 00M-1495, 00M-
1437, 00M-1475, 00M-1483, 00M-1515, 00M-1524, 00M-1523]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
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 applications (PMA's) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMA's through the Internet and the
agency's Dockets Management Branch.
ADDRESSES: Submit a written request for copies of summaries of safety
and effectiveness 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 of this
document when submitting a written request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the summary of safety and
effectiveness
FOR FURTHER INFORMATION CONTACT: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I. Background
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. Instead, 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 at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov on the Internet; 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
available safety and effectiveness summaries of approved PMA's 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)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the 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 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 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 approved PMA's for which summaries of
safety and effectiveness were placed on the Internet in accordance with
the procedure explained previously from July 1, 2000, through September
30, 2000. 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.
[[Page 78496]]
Table 1.--List of Safety and Effectiveness Summaries for Approved PMA's Made Available July 1, 2000, Through September 30, 2000
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PMA Number/Docket No. Applicant Trade Name Approval Date
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P930016(S7)/00M-1391 VISX, Inc. VISX STAR S2 Excimer Laser System November 2, 1998
P920030(S2)/00M-1536 Chiron Corp. CIBA Corning ACS PSA Immunoassay December 8, 1998
P910065(S1)/00M-1523 Tosoh Medics, Inc. AIA-PACK PA September 10, 1999
P990010/00M-1447 CRS Clinical Research, Inc. VISX Inc. Excimer Laser System Model C November 19, 1999
``STAR''
P940035(S2)/00M-1522 Matritech Inc. Matritech NMP22 Test Kit January 18, 2000
P990023/00M-0809 Alcon Laboratories Cellugel Ophthalmic February 24, 2000
Viscosurgical Device
P990054/00M-1517 Cardiac Pathways Corp. Chilli Cooled Ablation System March 17, 2000
H990014/00M-1451 Medtronic Inc. EnterraTM Therapy System (formerly named March 31, 2000
Gastric Electrical Stimulation (GES)
System)
P990053/00M-1448 Nellcor Puritan Bennett OxiFirst Fetal Oxygen May 12, 2000
Saturation Monitoring System
P990028/00M-1507 Focal, Inc. Focal Seal-L Synthetic Absorbable May 26, 2000
Sealant
P980050/00M-1389 Medtronic Inc. Medtronic Jewel AF June 14, 2000
7250 Dual Chamber Implantable
Cardioverter Defibrillator
P990025/00M-1388 Biosense Webster, Inc. NAVI-STAR Diagnostic/Ablation June 15, 2000
Deflectable Tip Catheter
P950032(S16)/00M-1508 Organogenesis, Inc. Apligraf (Graftskin) June 20, 2000
P99037/00M-1390 Vascular Solutions, Inc. Vascular Solutions Duett Sealing Device June 22, 2000
P990078/00M-1386 Sunrise Technologies Hyperion LTK System June 30, 2000
P990021/00M-1387 QLT Photo Therapeutics, Inc. Diomed 630 PDT Laser, Model T2USA June 30, 2000
P990018/00M-1414 Menicon USA, Inc. MeniconTM Z Rigid Gas Permeable Contact July 11, 2000
Lens
P000006/00M-1415 Mentor Corp. Alpha 1 Inflatable Penile Prosthesis July 14, 2000
P990064/00M-1416 Medtronic Inc. Mosaic Porcine Bioprosthesic July 14, 2000
Heart Valve
P990034/00M-1495 Medtronic Inc. Medtronic IsoMed July 21, 2000
Constant Flow Infusion System
P990039/00M-1437 Metra Biosystems, Inc. QUS-2TM Calcaneal Ultrasonometer August 1, 2000
P990072/00M-1475 Westcon Contact Lens Co., Inc. W-55 (Methafilcon A) and Horizon 55 Soft August 22, 2000
Extended Wear Contact Lenses
P860057(S11)/00M-1483 Edwards Lifesciences, LLC Carpentier-Edwards PERIMOUNT Pericardial August 28, 2000
Bioprosthesis
P970042/00M-1515 Medstone International, Inc. Medstone STSTM Lithotripter September 5, 2000
P990055/00M-1524 Bayer Corp. Bayer Immuno 1TM Complexed PSA Assay September 8, 2000
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/pmapage.html.
Dated: December 5, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-31960 Filed 12-14-00; 8:45 am]
BILLING CODE 4160-01-F