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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
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantMedifocus, Inc.
10240 Old Columbia Rd.
Suite G
Columbia, MD 21046
PMA NumberP030006
Supplement NumberS026
Date Received05/21/2014
Decision Date10/24/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REPLACING THE CURRENT SUPPLIER FOR MANIFOLD TUBING, AND TO REPLACE MEDICAL DEVICE ADHESIVE CURRENTLY USED IN MANUFACTURING.
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