[Federal Register: May 22, 2002 (Volume 67, Number 99)]
[Notices]
[Page 36009-36011]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my02-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 01M-0478, 01M-0460, 01M-0454, 01M-0453, 01M-0452, 01M-
0456, 01M-0451, 01M-0455, 01M-0578, 01M-0507, 01M-0579, 01M-0535, 01M-
0462, 01M-0461, 01M-0536, 01M-0520, 01M-0439, 01M-0509, 01M-0490, 01M-
0498, 01M-0479, 01M-0480, 01M-0482, 01M-0508, 01M-0522, 01M-0537, 01M-
0523, 01M-0530, 01M-0531, 01M-0534, 01M-0567, 01M-0581]
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 (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 Branch.
ADDRESSES: Submit written requests 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 summaries 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 Sec. 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
Sec. 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://
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 PMAs 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.
[[Page 36010]]
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 PMAs for which summaries of
safety and effectiveness were placed on the Internet in accordance with
the procedure explained previously from October 1, 2001, through
December 31, 2001. 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 October 1, 2001, through December 31, 2001
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PMA No./Docket Approval
No. Applicant Trade Name Date
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P990050/01M- Spectrascience, Optical Biopsy System November
0478 Inc. 14, 2000
P000020/01M- C.R. Bard, Inc. Stinger Ablation November
0460 Catheter Templink 29, 2000
Extension Cable
P990043/01M- Diasorin, Inc. DIASORIN ETI-EBK PLUS February 8,
0454 Assay 2001
P990042/01M- Diasorin, Inc. DIASORIN ETI-AB-AUK March 30,
0453 PLUS Assay 2001
P990041/01M- Diasorin, Inc. DIASORIN ETI-AB-EBK March 30,
0452 PLUS Assay 2001
P990045/01M- Diasorin, Inc. DIASORIN ETI-AB-COREK March 30,
0456 PLUS Assay 2001
P990038/01M- Diasorin, Inc. DIASORIN ETI MAK-2 PLUS March 30,
0451 Assay 2001
P990044/01M- Diasorin, Inc. DIASORIN ETI-CORE IGMK March 30,
0455 PLUS Assay 2001
P000040/01M- Bei Medical HYDROTHERMABLATOR April 20,
0578 Systems Co., Inc. Endometrial Ablation 2001
System
P990012/01M- Roche Diagnostics Elecsys Hbsag June 1,
0507 Corp. Immunoassay, Elecsys 2001
Hbsag Confirmatory,
and Precicontrol Hbsag
P000053/01M- American Medical AMS SPHINCTER 800 June 14,
0579 Systems, Inc. Urinary Control System 2001
P930027(S004)/ Diagnostic Immulite PSA, Immulite June 19,
01M-0535 Products Corp. Third Generation PSA, 2001
Immulite 2000
P880086(S083)/ St. Jude Medical, Integrity AFX DR Model July 11,
01M-0462 Inc. 5346 Dual Chamber 2001
Pulse Generator and
Programmer Software
Model 3307, V2.2a
P830045(S076)/ St. Jude Medical, Integrity AFX DR Model July 11,
01M-0461 Inc. 5346 Dual Chamber 2001
Pulse
P010021/01M- Ortho-Clinical Vitros Immunodiagnostic August 30,
0536 Diagnostics, Inc. Products Anti-HCV 2001
Reagent Pack and
Calibrator
P890057(S014)/ Sensor Medics Model 3100b High September
01M-0520 Corp. Frequency Oscillatory 24, 2001
Ventilator (HFOV)
P000029/01M- Q-Med Ab Deflux Injectable Gel September
0439 Ren 24, 2001
P010017/01M- Fisher Imaging SENOSCAN Full Field September
0509 Corp. Digital Mammagraphy 25, 2001
System
P980008(S005)/ Lasersight Lasersight Laserscan September
01M-0490 Technologies, Lsx Excimer Laser 28, 2001
Inc. System For Laser-
Assisted In Situ
Keratomileusis (LASIK)
P000036/01M- Advanced Tissue Dermagraft September
0498 Sciences 28, 2001
P010019/01M- Ciba Vision Corp. Focus Night And Day October 11,
0479 (Lotrafilcon A) Soft 2001
Contact Lenses
P000030/01M- Ciba Vision Corp. Focus Night & Day October 12,
0480 (Lotrafilcon A) Soft 2001
Contact Lenses
H010002/01M- Stryker Biotech OP-1 Implant October 17,
0482 2001
P000052/01M- Guidant Corp. Galileo Intravascular November 2,
0508 Radiotherapy System 2001
P930016(S014)/ VISX, Inc. VISX STAR Excimer Laser November 6,
01M-0522 System 2001
P010007/01M- Diagnostic Immulite/Immulite 2000 November 9,
0537 Products Corp. Afp Assays 2001
P990015/01M- Lifecore Intergel Adhesion November
0523 Biomedical, Inc. Prevention Solution 16, 2001
P000057/01M- Ascension Ascension Mcp November
0530 Orthopedics, Inc. 19, 2001
P980006(S004)/ Bausch & Lomb, Purevision (Balafilcon November
01M-0531 Inc. A) Visibility Tinted 20, 2001
Contact Lenses
P010032/01M- Advanced Genesis November
0534 Neuromodulation Neurostimulation (Ipg) 21, 2001
System, Inc. System
P010003/01M- Cryolife, Inc. BIOGLUE Surgical December 3,
0567 Adhesive 2001
P010020/01M- American Medical AMS Acticon December
0581 Systems, Inc. Neosphincter 18, 2001
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[[Page 36011]]
II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.
Dated: May 10, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-12728 Filed 5-21-02; 8:45 am]
BILLING CODE 4160-01-S