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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.
 
DevicePROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
MEDIFOCUS, INC
10240 old columbia road
suite g
columbia, MD 21046
PMA NumberP030006
Supplement NumberS005
Date Received03/23/2005
Decision Date06/30/2005
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
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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