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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 C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP910073
Supplement NumberS020
Date Received05/10/1996
Decision Date05/15/1996
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ENDOTAK C LEAD (MODELS 0060, 0062, 0064, 0065, 0066, 0067, AND 0068), ENDOTAK SQ PATCH LEAD (MODEL 0047 AND 0063), ENDOTAK C LEAD (MODELS 0070, 0072, 0073, 0074, 0075, 0113, AND 0115), ENDOTAK SQ LEAD ARRAY (MODELS 0048 AND 0049), AND ENDOTAK DSP LEAD (MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125), WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE
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