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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameKELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator, sensing lead and programmer
Regulation Number870.3610
ApplicantCOOK PACEMAKER CORP.
PMA NumberP870054
Date Received09/08/1987
Decision Date04/29/1988
Withdrawal Date 12/01/2004
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number 88M-0187
Notice Date 06/09/1988
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S009 S010 S011 
S014 
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