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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 MINI AICD SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS008
Date Received06/13/1995
Decision Date12/21/1995
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 THE VENTAK MINI AICD SYSTEM, WHICH INCLUDES:MODEL NUMBERS 1645, 1740, 1741, 1745, AND 1746 PULSE GENERATORS; MODEL 2840 SOFTWARE APPLICATION; MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU); AND MODEL 6996 DF-1 PLUG
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