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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.
 
DeviceENDOTAK(R) LEAD SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910073
Supplement NumberS015
Date Received05/01/1995
Decision Date11/27/1995
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 DECREASE IN THE LEAD BODY DIAMETER TO BE A MAXIMUM DIAMETER OF 10 FRENCH AND MODIFICATIONS IN THE LEAD COMPONENTS - THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDOTAK DSP LEAD MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125
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