[Federal Register Volume 60, Number 241 (Friday, December 15, 1995)]
[Notices]
[Pages 64439-64440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30611]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0396]
Karl Storz Endoscopy-America, Inc.; Premarket Approval of Storz
Modulith Lithotripter, Model SL20
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application by Karl Storz Endoscopy-America, Inc.,
Kennesaw, GA, for premarket approval, under the Federal Food, Drug, and
Cosmetic Act (the act), of the Storz Modulith Lithotripter, Model SL20.
FDA's Center for Devices and Radiological Health (CDRH) notified the
applicant, by letter of February 17, 1995, of the approval of the
application.
DATES: Petitions for administrative review by January 16, 1996.
ADDRESSES: Written requests for copies of the summary of safety and
effectiveness data and petitions for administrative review to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: John H. Baxley, Center for Devices and
Radiological Health (HFZ-472), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2194.
SUPPLEMENTARY INFORMATION: On November 24, 1993, Karl Storz Endoscopy-
America, Inc., Kennesaw, GA 30144, submitted to CDRH an application for
premarket approval of the Storz Modulith Lithotripter, Model SL20. The
device is an extracorporeal shock wave lithotripter and is indicated
for use in the noninvasive fragmentation of urinary calculi in the
kidney and upper ureter.
In accordance with the provisions of section 515(c)(2) of the act
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of
1990, this premarket approval application (PMA) was not referred to the
Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee, an FDA advisory committee, for review and
recommendation because the information in the PMA substantially
duplicates information previously reviewed by this panel.
On February 17, 1995, CDRH approved the application by a letter to
the applicant from the Director of the Office of Device Evaluation,
CDRH.
A summary of the safety and effectiveness data on which CDRH based
its approval is on file in the Dockets Management Branch (address
above) and is available from that office upon written request. Requests
should be identified with the name of the device and the docket number
found in brackets in the heading of this document.
Opportunity for Administrative Review
Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any
interested person to petition, under section 515(g) of the act, for
administrative review of CDRH's decision to approve this application. A
petitioner may request either a formal hearing under part 12 (21 CFR
part 12) of FDA's administrative practices and procedures regulations
or a review of the application and CDRH's
[[Page 64440]]
action by an independent advisory committee of experts. A petition is
to be in the form of a petition for reconsideration under Sec. 10.33(b)
(21 CFR 10.33(b)). A petitioner shall identify the form of review
requested (hearing or independent advisory committee) and shall submit
with the petition supporting data and information showing that there is
a genuine and substantial issue of material fact for resolution through
administrative review. After reviewing the petition, FDA will decide
whether to grant or deny the petition and will publish a notice of its
decision in the Federal Register. If FDA grants the petition, the
notice will state the issue to be reviewed, the form of review to be
used, the persons who may participate in the review, the time and place
where the review will occur, and other details.
Petitioners may, at any time on or before January 16, 1996, file
with the Dockets Management Branch (address above) two copies of each
petition and supporting data and information, identified with the name
of the device and the docket number found in brackets in the heading of
this document. Received petitions may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10)
and redelegated to the Director, Center for Devices and Radiological
Health (21 CFR 5.53).
Dated: December 4, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-30611 Filed 12-14-95; 8:45 am]
BILLING CODE 4160-01-F