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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.
 
DeviceBIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP830060
Supplement NumberS041
Date Received12/21/1995
Decision Date09/20/1996
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 MODELS 0012/0013 BIPOLAR ENDOCARDIAL LEADS; AND 0014/0015 POSITIVE-FIXATION PROTECTED-HELIX BIPOLAR ENDOCARDIAL LEADS TO BE USED IN CONJUNCTIO WITH AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR (AICD) PULSE GENERATORS
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