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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.
 
DeviceVENTAK(R) P3 AICD(TM) SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP930035
Supplement NumberS001
Date Received11/10/1994
Decision Date09/08/1995
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR VENTAK P3 W/VENTAK SOFTWARE MODULE, ENDOTAK C LEAD, ENDOTAK SQ PATCH LEAD, ENDOTAK SQ LEAD ARRAY, AICD Y CONNECTOR, EPICARDIAL PATCH LEAD; SOFTWARE MODULE MODEL 2836 REVISION 2.1 SOFTWARE; AND ALTERNATE STERILIZATION PROCESS
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