[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Notices]
[Page 36387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17473]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0202]
Intermedics, Inc.; Premarket Approval of Res-QTM ACD
(Arrhythmia Control Device) Epicardial Patch and Non-thoracotomy Lead
(NTL) Systems
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 Intermedics, Inc., Angleton, TX, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of Res-QTM ACD (Arrhythmia Control Device) Epicardial Patch
and NTL Systems. After reviewing the recommendation of the Circulatory
System Devices Panel, FDA's Center for Devices and Radiological Health
(CDRH) notified the applicant, by letter of November 28, 1995, of the
approval of the application.
DATES: Petitions for administrative review by August 9, 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: Carole C. Carey, Center for Devices
and Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8609.
SUPPLEMENTARY INFORMATION: On March 17, 1994, Intermedics, Inc.,
Angleton, TX 77515, submitted to CDRH an application for premarket
approval of Res-QTM ACD Epicardial Patch and NTL Systems which
consists of the following: Model 101-01 and 101-01R Res-QTM
implantable arrhythmia control device; model 531-30 Rx2OOO GRAPHICS
program module to be used with Intermedics commercially available model
522-06 Rx2OOO GRAPHICS programmer; models 497-05, 497-06, and 497-09
right ventricular (RV) defibrillation/pacing leads; model 497-15
subcutaneous patch lead; model 49716 superior vena cava (SVC) leads;
models 497-01, 497-02, 497-11, and 497-12 epicardial patch leads;
models A67 and L67 commercially available CPI epicardial
patch leads; model 370-01 adapter; model 370-21 Y-adapter; model 370-04
Test Box; models 370-03 and 370-23 Patient Cables; model 370-05 Test
Load; model 370-02 Accessory Kit; model 370-10 Lead Caps; and models
370-11, 370-12, 370-13, 370-14, 370-15, 370-16, 370-48, and 370-49
Stylets. The device is an automatic, implantable cardioverter-
defibrillator (ICD) system and is indicated for use in patients who are
at high risk of sudden death due to ventricular arrhythmias and have
experienced one of the following situations: (1) Survival of at least
one episode of cardiac arrest (manifested by a loss of consciousness)
due to a ventricular tachyrhythmia; or (2) recurrent, poorly tolerated
sustained ventricular tachycardia (VT).
Note: The clinical outcome for hemodynamically stable,
sustained-VT patients is not fully known. Safety and effectiveness
studies have not been conducted.
On August 21, 1995, the Circulatory System Devices Panel of the
Medical Devices Advisory Committee, an FDA advisory committee, review
and recommended approval of the application. On November 28, 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 (21
U.S.C. 360e(g)), 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 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 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 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 9, 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: April 9, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-17473 Filed 7-9-96; 8:45 am]
BILLING CODE 4160-01-F
