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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.
 
DeviceCCS MODEL 325 PACEMAKER SYSTEM
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantCARDIAC CONTROL SYSTEMS, INC.
3 COMMERCE BLVD.
PALM COAST, FL 32164
PMA NumberP890039
Supplement NumberS011
Date Received04/08/1993
Decision Date08/26/1993
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MAESTRO SAVVI MODEL 325 PULSE GENERATOR
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