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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 ENDOCARDIAL PACING LEADS
Generic Namepermanent pacemaker Electrode
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960004
Supplement NumberS010
Date Received09/14/1999
Decision Date03/29/2000
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the use of Nusil MED 4870 as an alternate material for the suture sleeve and extension of the shelf life of your devices to 4 years.
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