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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) MODEL 1006P PACEMAKER PROGRAMMER
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantCardiac Control Systems, Inc.
3 Commerce Blvd.
Palm Coast, FL 32164
PMA NumberP890039
Supplement NumberS002
Date Received01/04/1991
Decision Date04/25/1991
Product Code DXY 
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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