[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
