PMA P250011S006
- Device
- ProVee System for BPH
- Applicant
- Proverum, Ltd.
- PMA number
- P250011
- Supplement
- S006
- Product code
- MER
- Decision date
- 2026-09-24
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- the addition of a step to the ProVee System’s final assembly process.
Current openFDA PMA Record#
- Device
- ProVee System for BPH
- Applicant
- Proverum, Ltd.
- PMA number
- P250011
- Supplement
- S006
- Product code
- MER
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2026-09-24
- Decision code
- APPR
- Date received
- 2026-08-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a step to the ProVee System’s final assembly process.