[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Notices]
[Pages 68695-68696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31699]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 99M-0293, 99M-2168, 99M-2672, 99M-2605, 99M-2671, 99M-
2338, 99M-1167, 99M-1306, 99M-1073, 99M-2143, 99M-2606, 99M-2169, 99M-
2144, 99M-2748, 99M-2551, and 99M-4134]
Medical Devices; Availability of Safety and Effectiveness
Summaries for PMA
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 application (PMA) approvals. 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: Summaries of safety and effectiveness are available on the
Internet at http://www.fda.gov/cdrh/pmapage.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 at 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 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)(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 68696]]
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, 1999, through September
30, 1999. 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 July 1, 1999, through September 30, 1999
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PMA No./Docket
No. Applicant Trade Name Approval Date
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P930016(S5)/99M- Visx, Inc. Visx Excimer January 29, 1998
0293 Laser System
Models ``B''
P970032/99M-2168 BIEX, Inc. SalEstTM System April 29, 1998
P950015/99M-2672 PLC Medical The Heart August 20, 1998
Systems, Inc. LaserTM CO2
Laser System
for
Transmyocardial
Revascularizati
on
P980012/99M-2605 Baxter Healthcare Novacor LVAS 1998
P980035/99M-2671 Medtronic, Inc. Medtronic January 29, 1999
KappaTM 700/600
Series Pulse
Generators and
Model 9953
Software
P970029/99M-2238 Eclipse Surgical TMR Holmium February 11,
Technologies, Laser System 1999
Inc.
P980031/99M-1167 KeraVision, Inc. ICRS April 9, 1999
(Intrastromal
Corneal Ring
Segments)
P970004(S4)/99M- Medtronic, Inc. Medtronic April 15, 1999
1306 Interstim
Contenence
Control System
P970033/99M-1073 TransScan T-Scan 2000 April 16, 1999
Medical, Inc.
P980046/99M-2143 Home Access Hepatitis C April 28, 1999
Health Corp. CheckSM/Express
D970003/99M-2606 Guidant Corp. Guidant PULSARTM/ June 3, 1999
PULSAR MaxTM
P980022/99M-2169 Minimed Continuous June 15, 1999
Technologies, Glucose
Inc. Monitoring
System
P970018/99M-2144 AutoCyte, Inc. AutoCyte Prep June 17, 1999
System
P950021(S1)/99M- Bayer Corp. Bayer Immuno 1TM June 25, 1999
2748 PSA Assay
P980052/99M-2551 TMJ Concepts TMJ Concepts July 2, 1999
Patient-Fitted
TMJ
Reconstruction
Prosthesis
H990004/99M-4134 Nitinol Medical CardioSEAL September 8,
Technologies, Septal 1999
Inc. Occlusion
System
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Dated: November 24, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-31699 Filed 12-7-99; 8:45 am]
BILLING CODE 4160-01-F