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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.
 
DeviceKELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantCOOK PACEMAKER CORP.
ROUTE 66 RIVER RD.
P.O. BOX 529
LEECHBURG, PA 15656
PMA NumberP870054
Supplement NumberS006
Date Received04/25/1989
Decision Date07/31/1989
Withdrawal Date 12/01/2004
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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