[Federal Register: March 12, 2001 (Volume 66, Number 48)]
[Notices]
[Page 14390-14391]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr01-80]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 00M-1640, 00M-1664, 00M-1591, 00M-1613, 00M-1597, 00M-
1593, 00M-1583, 00M-1615, 00M-1612, 00M-1569, 00M-1658, 00M-1570, 00M-
1616, 00M-1659, 00M-1649, 00M-1650, 00M-1660, 00M-1661, 00M-1683, 00M-
1684]
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 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 X. 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://
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 October 1, 2000, through
December 31, 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.
Table 1.--List of Safety and Effectiveness Summaries for Approved PMA's
Made Available October 1, 2000, Through December 31, 2000
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PMA Number/
Docket No. Applicant Trade Name Approval Date
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P970053/00M- Nidek EC-5000 Excimer Laser December 17,
1640 Technologies, System 1998
Inc.
P970053(S1)/ Nidek EC-5000 Excimer Laser September 29,
00M-1664 Technologies, System (PARK) 1999
Inc.
P930034(S13)/ Summit SVS Apex Plus Excimer October 21,
00M-1591 Technologies Laser Workstation 1999
P990019/00M- DUSA BLU-U Light Photodynamic December 3,
1613 Pharmaceuticals Therapy Illuminator 1999
, Inc.
[[Page 14391]]
P990027/00M- Bausch & Lomb Technolas 217 February 23,
1597 Surgical, Inc. Excimer Laser System 2000
P970043(S5)/ Autonomous LADAR Vision May 9, 2000
00M-1593 Technologies Excimer Laser System
Corp.
P990052/00M- Symphonix Vibrant P/Vibrant D August 31,
1583 Devices, Inc. Soundbridge System 2000
P980010/00M- Osteometer DTU-One Ultrasound September 19,
1615 MediTech, Inc. Scanner 2000
P970043(S7)/ Autonomous LADAR Vision September 22,
00M-1612 Technologies Excimer Laser System 2000
Corp.
P990040/00M- Cordis Trufill N-Butyl September 25,
1569 Neurovascular, Cyanoacrylate Liquid 2000
Inc. Embolic System
P000014/00M- Ortho-Clinical VITROS Immunodiagnostic September 29,
1658 Diagnostics, Anti-HBS Reagent Pack 1999
Inc. and Calibrators
P990046/00M- ATS Medical, ATS Open Pivot October 13,
1570 Inc. Bileaflet Heart Valve 2000
N18286(S12)/ Pharmacia & Gelfoam October 16,
00M-1616 Upjohn Co. Sterile Powder 2000
P000015/00M- Cochlear Corp. Nucleus 24 Auditory October 20,
1659 Brainstem Implant (ABI) 2000
System
P000018/00M- Novoste Corp. Beta-CathTM System November 3,
1649 2000
P990036/00M- Cordis Corp. Cordis CheckmateTM November 3,
1650 System 2000
P990056/00M- Roche Elecsys Total November 22,
1660 Diagnostics, PSA Immunoassay and 2000
Corp. Calset
P990081/00M- Ventana Medical PathwayTM HER 2 November 28,
1661 Systems, Inc. 2000
P000027/00M- Roche Elecsys Free December 12,
1683 Diagnostics PSA Immunoassay/Calset/ 2000
Corp. Calcheck
P980020/00M- Q Care Q-103 Needle Management December 21,
1684 International, Systems 2000
LLC
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.
Dated: March 1, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 01-5954 Filed 3-9-01; 8:45 am]
BILLING CODE 4160-01-F