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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.
 
DeviceLEAD CAP ACCESSORY KIT
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP940008
Supplement NumberS015
Date Received06/26/2000
Decision Date10/05/2000
Withdrawal Date 07/20/2012
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 LEAD CAPS FOR USE WITH ALL GUIDANT COMPATIBLE LEADS INCLUDING THE RELIANCE(TM) AND RELIANCE S(TM) LEADS.
Post-Approval StudyShow Report Schedule and Study Progress
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