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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
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP960004
Supplement NumberS060
Date Received06/26/2013
Decision Date09/09/2013
Product Code
NVN[ Registered Establishments with NVN ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Review Memo Review 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 Order Approval Order
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