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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.
 
DeviceCADENCE FAMILY OF ICD'S
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS134
Date Received04/13/2007
Decision Date05/07/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
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