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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.
 
DeviceVH8500 HYPERTHERMIA TREATMENT SYSTEM
Generic NameApplicator, hyperthermia, interstitial
ApplicantCook, Inc.
P.O. Box 489
Bloomington, IN 47402
PMA NumberP880078
Supplement NumberS007
Date Received02/26/1992
Decision Date05/21/1992
Withdrawal Date06/30/2009
Product Code LMZ 
Advisory Committee Radiology
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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