PMA P250011S002
- Device
- ProVee System for BPH
- Applicant
- Proverum, Ltd.
- PMA number
- P250011
- Supplement
- S002
- Product code
- MER
- Decision date
- 2026-06-03
- Classification
- Gastroenterology, Urology
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Approval order statement
- to increase the routine bioburden sampling size from 3 to 5 units per sampling period
Current openFDA PMA Record#
- Device
- ProVee System for BPH
- Applicant
- Proverum, Ltd.
- PMA number
- P250011
- Supplement
- S002
- Product code
- MER
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Decision date
- 2026-06-03
- Decision code
- OK30
- Date received
- 2026-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to increase the routine bioburden sampling size from 3 to 5 units per sampling period