The in. Pact av paclitaxel-coated pta balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
| Device | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter |
| Classification Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Applicant | Medtronic Vascular Inc. |
| Date Received | 2019-04-03 |
| Decision Date | 2019-11-21 |
| PMA | P190008 |
| Supplement | S |
| Product Code | PRC |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medtronic Vascular Inc. 3576 Unocal Place santa Rosa, CA 95403 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190008 | Original Filing | |
| S022 | 2022-11-29 | 30-day Notice |
| S021 | 2022-10-31 | 30-day Notice |
| S020 | 2022-09-29 | 30-day Notice |
| S019 | 2022-06-28 | 30-day Notice |
| S018 | 2022-02-04 | Normal 180 Day Track No User Fee |
| S017 | 2021-11-12 | 30-day Notice |
| S016 | 2021-06-21 | 30-day Notice |
| S015 | ||
| S014 | 2021-04-23 | Special (immediate Track) |
| S013 | 2021-03-04 | 30-day Notice |
| S012 | ||
| S011 | 2021-02-25 | 30-day Notice |
| S010 | 2021-01-19 | Normal 180 Day Track No User Fee |
| S009 | 2021-01-19 | 30-day Notice |
| S008 | 2020-11-23 | 30-day Notice |
| S007 | ||
| S006 | 2020-10-02 | 30-day Notice |
| S005 | 2020-08-12 | Normal 180 Day Track No User Fee |
| S004 | 2020-06-26 | Real-time Process |
| S003 | 2020-05-28 | Normal 180 Day Track No User Fee |
| S002 | 2020-01-23 | 30-day Notice |
| S001 |