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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.
 
DeviceMAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantCardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast, FL 32164
PMA NumberP890039
Supplement NumberS015
Date Received12/26/1995
Decision Date07/09/1996
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE STERILIZATION PROCEDURE
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