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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.
 
DeviceProVee System for BPH
Generic NameSTENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
ApplicantProverum, Ltd.
2nd Floor Astor Hall, 4-8 Eden Quay
Dublin D01N5W8
PMA NumberP250011
Supplement NumberS002
Date Received05/06/2026
Decision Date06/03/2026
Product Code MER 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to increase the routine bioburden sampling size from 3 to 5 units per sampling period
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