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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.
 
DeviceSELUTE(R) PICOTIP(TM) STEROID-ELUTING ENDOCARDIAL ATRIAL-J LEADS
Generic NamePermanent defibrillator electrodes
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP950001
Supplement NumberS004
Date Received11/15/1999
Decision Date05/10/2000
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Atrial J SELUTE PICOTIP Steroid Eluting Pacing Lead, Models 4063 and 4064.
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