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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 NameMAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacing system
Regulation Number870.3610
ApplicantCARDIAC CONTROL SYSTEMS, INC.
PMA NumberP890039
Supplement NumberS015
Date Received12/26/1995
Decision Date07/09/1996
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization procedure.
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