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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.
 
DevicePROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantMedifocus, Inc.
10240 Old Columbia Rd.
Suite G
Columbia, MD 21046
PMA NumberP030006
Supplement NumberS005
Date Received03/23/2005
Decision Date06/30/2005
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ACCELLENT JUAREZ (MANUFACTURING SITE) LOCATED IN, CHIHUAHUA, MEXICO; ACCELLENT EL PASO (WAREHOUSE) LOCATED IN EL PASO, TEXAS; AND STERIGENICS INTERNATIONAL, INC. (STERILIZER) LOCATED IN SANTA TERESA, NEW MEXICO.
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