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.
Approval for an extension of the shelf life of the freepac coating solution from 7 to 14 days.
| Device | IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMICAL ANGIOPLASTLY BALLOON CATHETER |
| Classification Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2015-07-10 |
| Decision Date | 2015-07-24 |
| PMA | P140010 |
| Supplement | S007 |
| Product Code | ONU |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDTRONIC Inc. 3576 Unocal Pl santa Rosa, CA 95403 |
| 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 |