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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 HE AND VENTAK MINI III AICD TM SYSTEMS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910077
Supplement NumberS022
Date Received07/28/1997
Decision Date01/23/1998
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 higher shock energy for the VENTAK MINI HE, the downsized VENTAK MINI III, revisions to the VENTAK MINI Application Software-Model 2840, and labeling revisions ot indicate shock energy as joules "stored" and updating the indications for use.
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