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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
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
COOK PACEMAKER CORP.
route 66 river rd.
p.o. box 529
leechburg, PA 15656
PMA NumberP870054
Supplement NumberS002
Date Received01/17/1989
Decision Date03/22/1989
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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