Optilume Urethral Drug Coated Balloon
FDA premarket approval P210020/S004 · decided 2022-05-17
Approval details
- PMA number
- P210020
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Optilume Urethral Drug Coated Balloon
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Applicant
- Urotronic, Inc.
- Date received
- 2022-02-24
- Decision date
- 2022-05-17
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- QRH
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for validation of a new Low EO sterilization cycle utilizing a lower ethylene oxide (EO) concentration and lower EO dwell time.
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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 |