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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 MODEL 534 PACEMAKER SYSTEM
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantCardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast, FL 32164
PMA NumberP860027
Supplement NumberS012
Date Received06/12/1997
Decision Date07/29/1997
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MAESTRO II MODEL 534 PACEMAKER SYSTEM.
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