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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. MODELS 501, 505, 509
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantCardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast, FL 32164
PMA NumberP860027
Supplement NumberS002
Date Received02/17/1988
Decision Date12/28/1988
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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