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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.
 
DeviceFLEXTEND LEAD
Generic NamePermanent defibrillator electrodes
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960006
Supplement NumberS038
Date Received03/19/2013
Decision Date05/07/2013
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR AN ALTERNATE PRIMER MATERIAL FOR THE FLEXTEND AND ACTIVE FIXATION RELIANCE IS-1/4-SITE LEADS.
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