This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
For the in. Pact admiral paclitaxel-coated percutaneous transluminal angioplasty (pta) balloon catheter. This device is indicated for percutaneous transluminal angioplasty, after predilatation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
| Device | IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
| Classification Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2014-05-29 |
| Decision Date | 2014-12-30 |
| Notice Date | 2015-01-20 |
| PMA | P140010 |
| Supplement | S |
| Product Code | ONU |
| Docket Number | 15M-0199 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC Inc. 3576 Unocal Pl santa Rosa, CA 95403 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140010 | Original Filing | |
| S071 | 2022-11-29 | 30-day Notice |
| S070 | 2022-10-31 | 30-day Notice |
| S069 | ||
| S068 | 2022-09-29 | 30-day Notice |
| S067 | 2022-08-26 | 30-day Notice |
| S066 | 2022-06-28 | 30-day Notice |
| S065 | ||
| S064 | 2022-06-14 | 30-day Notice |
| S063 | 2021-11-12 | 30-day Notice |
| S062 | ||
| S061 | ||
| S060 | 2021-04-23 | Special (immediate Track) |
| S059 | 2021-03-30 | 30-day Notice |
| S058 | 2021-03-04 | 30-day Notice |
| S057 | ||
| S056 | 2021-02-25 | 30-day Notice |
| S055 | 2021-01-19 | 30-day Notice |
| S054 | 2020-11-23 | 30-day Notice |
| S053 | ||
| S052 | 2020-10-02 | 30-day Notice |
| S051 | 2020-07-10 | Normal 180 Day Track No User Fee |
| S050 | ||
| S049 | 2020-01-23 | 30-day Notice |
| S048 | 2019-11-20 | 30-day Notice |
| S047 | 2019-08-30 | Special (immediate Track) |
| S046 | 2019-05-31 | 30-day Notice |
| S045 | 2019-05-02 | 30-day Notice |
| S044 | 2019-04-11 | 30-day Notice |
| S043 | 2018-10-25 | Real-time Process |
| S042 | 2018-10-10 | Normal 180 Day Track No User Fee |
| S041 | 2018-09-24 | 30-day Notice |
| S040 | ||
| S039 | 2018-03-19 | Normal 180 Day Track |
| S038 | ||
| S037 | 2017-12-08 | Panel Track |
| S036 | 2017-07-20 | 30-day Notice |
| S035 | 2017-06-28 | 30-day Notice |
| S034 | 2017-06-13 | 30-day Notice |
| S033 | 2017-06-01 | 135 Review Track For 30-day Notice |
| S032 | 2017-05-25 | Real-time Process |
| S031 | 2017-04-18 | 30-day Notice |
| S030 | 2017-03-08 | 30-day Notice |
| S029 | 2017-02-17 | 30-day Notice |
| S028 | 2017-01-12 | 30-day Notice |
| S027 | 2016-11-18 | 30-day Notice |
| S026 | 2016-10-07 | Normal 180 Day Track No User Fee |
| S025 | 2016-09-12 | 30-day Notice |
| S024 | 2016-08-02 | 135 Review Track For 30-day Notice |
| S023 | 2016-07-29 | Normal 180 Day Track No User Fee |
| S022 | 2016-07-19 | 30-day Notice |
| S021 | 2016-07-13 | 30-day Notice |
| S020 | 2016-06-20 | 30-day Notice |
| S019 | 2016-05-26 | 30-day Notice |
| S018 | 2016-05-25 | 135 Review Track For 30-day Notice |
| S017 | 2016-04-06 | Special (immediate Track) |
| S016 | 2016-03-22 | 30-day Notice |
| S015 | 2016-03-11 | Panel Track |
| S014 | 2016-03-02 | 30-day Notice |
| S013 | 2015-11-24 | Normal 180 Day Track |
| S012 | 2015-11-05 | 135 Review Track For 30-day Notice |
| S011 | 2015-10-28 | 30-day Notice |
| S010 | 2015-09-18 | 30-day Notice |
| S009 | 2015-07-21 | Normal 180 Day Track No User Fee |
| S008 | ||
| S007 | 2015-07-10 | Real-time Process |
| S006 | 2015-04-21 | Real-time Process |
| S005 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S004 | 2015-03-18 | 30-day Notice |
| S003 | 2015-01-27 | Normal 180 Day Track No User Fee |
| S002 | 2015-01-26 | Normal 180 Day Track No User Fee |
| S001 | 2014-12-30 | 30-day Notice |