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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP910023
Supplement NumberS047
Date Received06/14/2000
Decision Date10/27/2000
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 01M-0041
Notice Date 01/29/2001
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the photon(tm) dr icd system programmer software, model ac-ip is-1 receptable plug, and model 442-2 torque driver/torque wrench. The device is indicated for use in patients with a history of hemodynamically compromising ventricular tachyarrhythmias. These patients may have experienced a cardiac arrest not associated with acute myocardial infarction or have ventricular tachyarrhythmias. In addition, the pulse generator can be used in patients whose primary therapy for hemodynamically significant, sustained ventricular tachycardia is antitachycardia pacing; the defibrillation capabilities of the device provide high-energy therapy in the event that the arrhythmia accelerates. The pulse generator can be implanted in either the pectoral region or the abdominal region, at the physician's discretion.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling