[Federal Register Volume 59, Number 113 (Tuesday, June 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14315]


[[Page Unknown]]

[Federal Register: June 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0180]

 

Sigmedics, Inc.; Premarket Approval of Parastep I 
System

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 Sigmedics, Inc., Northfield, IL, for 
premarket approval, under section 515 of the Federal Food, Drug, and 
Cosmetic Act (the act), of the Parastep I System. After 
reviewing the recommendation of the Orthopedic and Rehabilitation 
Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) 
notified the applicant, by letter of April 20, 1994, of the approval of 
the application.
DATES: Petitions for administrative review by July 14, 1994.

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, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Marie A. Schroeder, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration,1390 
Piccard Dr., Rockville, MD 20850, 301-594-1296.

SUPPLEMENTARY INFORMATION: On September 30, 1992, Sigmedics, Inc., One 
Northfield Plaza, suite 410, Northfield, IL 60093-3016, submitted to 
CDRH, an application for premarket approval of the Parastep I 
System. The device is a noninvasive functional neuromuscular stimulator 
for ambulation and is indicated for enabling appropriately selected 
skeletally mature spinal cord injured patients (levels C6-T12) to stand 
and to attain limited ambulation and/or take steps, with assistance if 
required, following a prescribed period of physical therapy training in 
conjunction with rehabilitation management of spinal cord injury.
    On August 19, 1993, the Orthopedic and Rehabilitation Devices 
Panel, an FDA advisory committee, reviewed and recommended approval of 
the application. On April 20, 1994, CDRH approved the application by a 
letter to the applicant from the Acting 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 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 July 14, 1994, 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 Center for Devices and Radiological Health (21 
CFR 5.53).

    Dated: May 31, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-14315 Filed 6-13-94; 8:45 am]
BILLING CODE 4160-01-F