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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: DSP, ENDURANCE EZ, AND ENDURANCE RX LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910073
Supplement NumberS038
Date Received11/21/2001
Decision Date01/11/2002
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE PEEK SUPPORT CLIP FOR THE ENDOTAK DSP LEAD MODELS 0094, 0095, 0125, ENDOTAK ENDURANCE LEAD MODELS 0134, 0135, 0136 AND ENDOTAK ENDURANCE EZ LEAD MODELS 0154, 0155 AND 0156.
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