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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 PACING LEADS MODELS 4086, 4087, 4088, AND FIXATIO NTOOL MODEL 6616
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960006
Supplement NumberS005
Date Received07/11/2001
Decision Date02/04/2002
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FLEXTEND PACING LEADS MODELS 4086, 4087, 4088, AND FIXATION TOOL MODEL 6616. THE FLEXTEND PACING LEADS MODELS 4086, 4087, AND 4088 ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
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