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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 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.
 
DevicePROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER)
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS053
Date Received06/28/2001
Decision Date07/18/2001
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF A NEW BATTERY MODEL (WGL 2150) FOR THE LEGALLY MARKETED ST. JUDE MEPRO MD (MODELS V-186F AND V-1 DR (MODEL V-230HV) AND P 5 VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-194 AND V-232). IN ADDITION, THE SUPPLEMENT REQUESTED APPROVAL FOR THE USE OF AN ALTERNATE IS-1 RECEPTACLE PLUG, MODEL AC-IP-2, FOR TH 5 DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE MD (MODELS V-186F AND V-1 DR (MODEL V-230HV) IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND ARE 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, THESE PULSE GENERATORS CAN BE USED IN PATIENTS WHOSE PRIMARY THERAPY FOR HEMODYNAMICALLY SIGNIFICANT, SUSTAINED VENTRICULAR TACHYCARDIA IS ANTI-TACHYCARDIA PACING; THE DEFIBRILLATION CAPABILITIES OF THESE DEVICES PROVIDE HIGH-ENERGY THERAPY IN THE EVENT THAT THE ARRHYTHMIA ACCELERATES. THE PULSE GENERATORS CAN BE IMPLANTED IN EITHER THE PECTORAL REGION OR THE ABDOMINAL REGION, AT THE PHYSICIAN'S DISCRETION. THE PHOTON 5 VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (MODELS V-194 AND V-232) ARE INTENDED TO PROVIDE VENTRICULAR ANTI-TACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
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