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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.
 
DeviceTENDRIL DX, MODELS 1388 T/K & TENDRIL SDX MODELS 1488 T/K
Generic Namepermanent pacemaker Electrode
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS012
Date Received12/04/2002
Decision Date01/22/2003
Product Codes DTB DXY 
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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