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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 II STEROX LEAD
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantBoston Scientific
4100 Hamline Ave. N.
Alternate Contact, MN 55112
PMA NumberP960004
Supplement NumberS060
Date Received06/26/2013
Decision Date09/09/2013
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL TO CHANGE THE PRIMER FORMULATION USED ON FINELINE II LEADSUBASSEMBLIES, AS WELL AS TO RELOCATE MANUFACTURING OF SOME SUBASSEMBLIES IN-HOUSE WITH MINOR ASSOCIATED DESIGN CHANGES.
Approval OrderApproval Order
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