- Device
- ProVee System for BPH
- Applicant
- Proverum, Ltd.
- PMA number
- P250011
- Supplement
- S004
- Product code
- MER
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2026-07-01
- Decision code
- OK30
- Date received
- 2026-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- To update the steering sheath component vertical heat shrinker reflow manufacturing procedure with the sheath supplier, and reduce the occurrence rate of bubble/void reflow defects in the steering sheath