Optilume Urethral Drug Coated Balloon
FDA premarket approval P210020 · decided 2021-12-03
Approval details
- PMA number
- P210020
- Trade name
- Optilume Urethral Drug Coated Balloon
- Generic name
- Catheter, Balloon, Urethral, Drug-Coated
- Applicant
- Urotronic, Inc.
- Date received
- 2021-05-11
- Decision date
- 2021-12-03
- Days to decision
- 206 days
- Decision code
- APPR
- Product code
- QRH
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval of the Optilume® Urethral Drug Coated Balloon. The device is used to treat patients with obstructive urinary symptoms associated with anterior urethral stricture. It is designed to be used in adult males for urethral strictures of less than or equal to 3 cm in length.
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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 |