Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ST JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND B-235) |
Generic Name | Programmer, pacemaker |
Regulation Number | 870.3700 |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S081 |
Date Received | 07/17/2002 |
Decision Date | 07/30/2002 |
Withdrawal Date
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06/20/2007 |
Product Code |
KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DOWNSIZED VERSION OF THE PHOTON UDR/VR DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL EPIC VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-197 AND V235) AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. |
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