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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 ICDS
Generic NamePulse generator, permanent, implantable
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS202
Date Received02/17/2009
Decision Date03/23/2009
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MODIFICATIONS OF THE C64 IC (VERSION P) FOR THE EPIC II / ATLAS II PLATFORM OF ICDS, AND SIO2 IC (VERSION G) FOR THE EPIC+ / ATLAS+ AND EPIC II / ATLAS II PLATFORM OF ICDS.
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