ProVee System for BPH
FDA premarket approval P250011 · decided 2025-12-09
Approval details
- PMA number
- P250011
- Trade name
- ProVee System for BPH
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Applicant
- Proverum, Ltd.
- Date received
- 2025-04-02
- Decision date
- 2025-12-09
- Days to decision
- 251 days
- Decision code
- APPR
- Product code
- MER
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- The ProVee System for BPH is intended for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths greater than or equal to 3.75 cm and prostatic volumes between 30 and 80 cc.
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