[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Page 37067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17973]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0253]


Medispec, Ltd.; Premarket Approval of EconolithTM 
Extracorporeal Shock Wave Lithotripter

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 Medispec Ltd., Rockville, MD, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the Medispec Ltd., EconolithTM Lithotripter. FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of April 7, 1997, of the approval of the 
application.

DATES: Petitions for administrative review by August 11, 1997.

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: Russell P. Pagano, Center for Devices 
and Radiological Health (HFZ-472), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION: On December 26, 1995, Medispec Ltd., 
Rockville, MD, 20850, submitted to CDRH an application for premarket 
approval of the EconolithTM Lithotripter. The device is an 
extracorporeal shockwave lithotripter and is indicated for use in the 
noninvasive fragmentation of upper urinary tract stones between 5 and 
20 millimeters in size.
    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 April 7, 1997, CDRH approved the application by a letter to the 
applicant from the Deputy Director, Clinical and Review Policy, 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 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 21 CFR part 12 of FDA's administrative 
practices and procedures regulations or a review of the application and 
CDRH's action by an independent advisory committee of experts. A 
petition is to be in the form of a petition for reconsideration under 
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 the 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 August 11, 1997 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: June 10, 1997.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-17973 Filed 7-9-97; 8:45 am]
BILLING CODE 4160-01-F