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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCCS MODEL 325 PACEMAKER SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
ApplicantCARDIAC CONTROL SYSTEMS, INC.
PMA NumberP890039
Supplement NumberS011
Date Received04/08/1993
Decision Date08/26/1993
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the maestro savvi model 325 pulse generator.
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