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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/THINLINE II BRADY LEADS
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960004
Supplement NumberS042
Date Received12/08/2008
Decision Date06/05/2009
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A NEW SUPPLIER, OPTINOVA, AND CHANGES IN SPECIFICATIONS FOR FOREIGN MATTER, GELS, AND BUBBLES FOR THE POLYURETHANE TUBING LEAD BODY USED IN THE DEVICE.
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