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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.
 
DevicePASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960030
Supplement NumberS009
Date Received12/04/2002
Decision Date01/22/2003
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS.
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