This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Optilume Urethral Drug Coated Balloon |
| Generic Name | Catheter, Balloon, Urethral, Drug-coated |
| Applicant | Urotronic, Inc.2495 Xenium Laneminneapolis, MN 55441 PMA NumberP210020 Supplement NumberS006 Date Received08/30/2022 Decision Date09/29/2022 Product Code QRH Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-08-30 |
| Decision Date | 2022-09-29 |
| PMA | P210020 |
| Supplement | S006 |
| 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 PMA NumberP210020 Supplement NumberS006 Date Received08/30/2022 Decision Date09/29/2022 Product Code QRH Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductYes Approval Order Statement approval Of The Revised 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. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00853095008334 | P210020 | 000 |
| 00853095008327 | P210020 | 000 |
| 00853095008310 | P210020 | 000 |
| 00853095008303 | P210020 | 000 |
| 00853095008297 | P210020 | 000 |
| 00853095008280 | P210020 | 000 |
| 00853095008273 | P210020 | 000 |
| 00853095008242 | P210020 | 000 |