Optilume BPH Catheter System
FDA premarket approval P220029/S003 · decided 2025-12-15
Approval details
- PMA number
- P220029
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Optilume BPH Catheter System
- Generic name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia
- Applicant
- Urotronic, Inc.
- Date received
- 2025-11-17
- Decision date
- 2025-12-15
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- QXB
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval of the revised protocol for the post-approval study (PAS)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Optilume® High Pressure Urological Balloon Dilation Catheter (K250910) | Urotronic, Inc. | 2025-05-22 |
| Optilume Basic Urological Balloon Dilation Catheter (K191061) | Urotronic, Inc. | 2020-01-02 |