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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 ACID FAMILY SYSTEMS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS025
Date Received09/10/1998
Decision Date12/02/1998
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(R) MINI(TM) IV Models 1790, 1792, 1793, and 1796; VENTAK(R) MINI(TM) III+HE Models 1788 and 1789; VENTAK(R) MINI(TM) Application Software Model 2840 (Version 4.0); and the sensitivity adjustment for VENTAK(R) MINI(TM) and MINI(TM) II ICD systems.
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