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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameKELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS.
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator, sensing lead and programmer
Regulation Number870.3610
ApplicantCOOK PACEMAKER CORP.
PMA NumberP870054
Supplement NumberS014
Date Received06/08/1995
Decision Date07/12/1995
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the accelerated burn-in procedure on the lithium/iodine power source (battery) by the vendor.
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