The optilume® urethral drug coated balloon 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.
| Device | 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 |
| PMA | P210020 |
| Supplement | S |
| Product Code | QRH |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Urotronic, Inc. 2495 Xenium Lane minneapolis, MN 55441 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P210020 | | Original Filing |
| S006 |
2022-08-30 |
Normal 180 Day Track No User Fee |
| S005 |
2022-05-12 |
Normal 180 Day Track No User Fee |
| S004 |
2022-02-24 |
Real-time Process |
| S003 |
2022-01-05 |
Normal 180 Day Track No User Fee |
| S002 |
2021-12-28 |
Normal 180 Day Track No User Fee |
| S001 |
2021-12-20 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices