Optilume BPH Catheter System
FDA premarket approval P220029/S004 · decided 2025-12-12
Approval details
- PMA number
- P220029
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Optilume BPH Catheter System
- Generic name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia
- Applicant
- Urotronic, Inc.
- Date received
- 2025-11-25
- Decision date
- 2025-12-12
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- QXB
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- a change of an additional pre-dilation catheter supplier manufacturing site
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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 |