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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 FAMILY OF PACING LEADS
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960006
Supplement NumberS016
Date Received07/05/2005
Decision Date08/04/2005
Product Code DTB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
ADDITION OF PRIMER TO THE INNER SURFACE OF THE ELECTRODE RING OF THE FLEXTEND LEADS TO INCREASE ADHESION OF THE ELECTRODE RING TO THE MOLDED NECK.
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