[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