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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 PRX AND VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) FAMILIES
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910077
Supplement NumberS122
Date Received07/26/2012
Decision Date10/05/2012
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE USE OF A LONGER STERILE BARRIER TYVEK POUCH AS PRIMARY PACKAGING FOR THE BSC CRV LEADS ACCESSORY PRODUCTS.
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