[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]



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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.

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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]
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