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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.
 
DeviceTHINLINE II STEROX /FINELINE II STEROX ENDOCARDIAL PACING LEADS
Generic Namepermanent pacemaker Electrode
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960004
Supplement NumberS022
Date Received06/03/2003
Decision Date07/02/2003
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A BIOCOMPATIBLE ADHESIVE TO THE LEAD WHICH WILL ENHANCE THE ABILITY TO MAINTAIN THE POSITION OF THE DRUG-ELUTING COLLAR AT ITS DESIGNED LOCATION.
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