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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 LEADS MODELS 1788 & 1782
Generic NamePulse generator, permanent, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS033
Date Received05/11/2007
Decision Date06/26/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR RING ELECTRODE MODIFICATIONS TO TENDRIL 1788 AND 1782 LEADS, AND AN OUTER INSULATION TUBE DIAMETER CHANGE FOR TENDRIL 1782 LEADS.
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