- Device
- ProVee System for BPH
- Applicant
- Proverum, Ltd.
- PMA number
- P250011
- Supplement
- S001
- Product code
- MER
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2026-03-19
- Decision code
- APPR
- Date received
- 2026-02-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- a revised precaution statement recommending use of a straight catheter in patients with the ProVee implant who need catheterization