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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 SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantCARDIAC CONTROL SYSTEMS, INC.
3 COMMERCE BLVD.
PALM COAST, FL 32164
PMA NumberP860027
Supplement NumberS007
Date Received11/08/1990
Decision Date01/30/1991
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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