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 NumberS004 Date Received02/24/2022 Decision Date05/17/2022 Product Code QRH Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-24 |
| Decision Date | 2022-05-17 |
| PMA | P210020 |
| Supplement | S004 |
| Product Code | QRH |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Urotronic, Inc. 2495 Xenium Lane minneapolis, MN 55441 PMA NumberP210020 Supplement NumberS004 Date Received02/24/2022 Decision Date05/17/2022 Product Code QRH Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement approval For Validation Of A New Low EO Sterilization Cycle Utilizing A Lower Ethylene Oxide (EO) Concentration And Lower EO Dwell Time |
| 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 |