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 a manufacturing site located at medtronic mexico, tijuana, baja california, mexico.
| Device | IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL BALLOON CATHETER |
| Classification Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2015-07-21 |
| Decision Date | 2015-12-04 |
| PMA | P140010 |
| Supplement | S009 |
| Product Code | ONU |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |