Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p210020.
| Device | Optilume Urethral Drug Coated Balloon |
| Generic Name | Catheter, Balloon, Urethral, Drug-coated |
| Applicant | Urotronic, Inc. |
| Date Received | 2021-12-20 |
| Decision Date | 2022-01-19 |
| PMA | P210020 |
| Supplement | S001 |
| Product Code | QRH |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| 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