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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) PRX (TM) II AICD SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS011
Date Received08/25/1995
Decision Date02/05/1996
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF MODEL 2872 SOFTWARE APPLICATION, REV. 4.1 AND MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) WITH THE VENTAK PRX II/III PULSE GENERATOR AND MODEL 2950 PRM
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