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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.
 
DeviceFINELINE FAMILY INCLUDES FINELINE, FINELINE II
Generic Namepermanent pacemaker Electrode
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960004
Supplement NumberS028
Date Received02/24/2005
Decision Date03/24/2005
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.
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