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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePASSIVE PLUS DX, MODELS 1336T, 1342T, 1343K, 1345K, 1346T
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP960030
Supplement NumberS009
Date Received12/04/2002
Decision Date01/22/2003
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for extending the shelf life of st. Jude medical steroid-eluting bradycardia leads.
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