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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.
 
DeviceVOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500
Generic NameApplicator, hyperthermia, interstitial
ApplicantCOOK, INC.
P.O. BOX 489
BLOOMINGTON, IN 47402
PMA NumberP880078
Supplement NumberS006
Date Received12/13/1991
Decision Date02/25/1992
Withdrawal Date 06/30/2009
Product Code LMZ 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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