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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 NumberS001
Date Received02/18/2026
Decision Date03/19/2026
Product Code MER 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a revised precaution statement recommending use of a straight catheter in patients with the ProVee implant who need catheterization
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