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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 FAMILY OF LEADS
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS029
Date Received03/19/2007
Decision Date08/06/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE CIRCUMFERENTIAL WELD TO THE CURRENT MULTIPLE SPOT WELDS TO CONNECT THE INNER COIL TO THE HELIX SHAFT.
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