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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 MODEL 1488T/TC AND 1688T/TC LEADS
Generic Namepermanent pacemaker Electrode
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS016
Date Received02/06/2006
Decision Date03/02/2006
Product Codes DTB NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF AN INSPECTION FOR MEDICAL ADHESIVE ON THE HELIX DURING PRODUCTION.
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