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.
The update of the thermoformed packaging trays drawings, the implementation of an inspection test method, and the documentation/procedures updates associated with the transfer of a supplier to a quality program
| Device | Implantable System for Remodulin |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | Medtronic, Inc. |
| Date Received | 2019-05-06 |
| Decision Date | 2019-06-03 |
| PMA | P140032 |
| Supplement | S034 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Medtronic, Inc. 710 Medtronic Parkway Ne minneapolis, MN 55432-5604 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140032 | Original Filing | |
| S074 | 2021-08-04 | Normal 180 Day Track No User Fee |
| S073 | 2021-06-21 | 30-day Notice |
| S072 | 2021-05-28 | 30-day Notice |
| S071 | 2021-05-04 | 30-day Notice |
| S070 | 2021-04-09 | 30-day Notice |
| S069 | 2021-04-08 | 30-day Notice |
| S068 | 2021-03-08 | 30-day Notice |
| S067 | 2021-02-25 | 30-day Notice |
| S066 | ||
| S065 | 2020-12-11 | 30-day Notice |
| S064 | 2020-11-18 | 30-day Notice |
| S063 | 2020-11-03 | 30-day Notice |
| S062 | 2020-10-20 | 30-day Notice |
| S061 | 2020-08-26 | Real-time Process |
| S060 | 2020-08-11 | 30-day Notice |
| S059 | 2020-08-07 | 30-day Notice |
| S058 | ||
| S057 | ||
| S056 | 2020-05-11 | 30-day Notice |
| S055 | 2020-04-24 | 30-day Notice |
| S054 | 2020-04-16 | 30-day Notice |
| S053 | 2020-04-09 | 30-day Notice |
| S052 | 2020-03-23 | 30-day Notice |
| S051 | 2020-03-11 | 30-day Notice |
| S050 | 2020-03-09 | 30-day Notice |
| S049 | ||
| S048 | 2019-12-23 | Special (immediate Track) |
| S047 | ||
| S046 | 2019-12-10 | 30-day Notice |
| S045 | 2019-12-10 | 30-day Notice |
| S044 | 2019-11-25 | 30-day Notice |
| S043 | 2019-11-15 | 30-day Notice |
| S042 | 2019-09-27 | 30-day Notice |
| S041 | 2019-08-30 | 30-day Notice |
| S040 | 2019-08-09 | 30-day Notice |
| S039 | 2019-08-08 | 30-day Notice |
| S038 | 2019-07-26 | 30-day Notice |
| S037 | 2019-07-16 | 30-day Notice |
| S036 | ||
| S035 | 2019-06-06 | 30-day Notice |
| S034 | 2019-05-06 | 30-day Notice |
| S033 | 2019-04-26 | 30-day Notice |
| S032 | ||
| S031 | 2019-04-01 | 30-day Notice |
| S030 | 2019-03-07 | 30-day Notice |
| S029 | 2019-02-28 | 30-day Notice |
| S028 | 2019-02-27 | 30-day Notice |
| S027 | 2019-02-22 | 30-day Notice |
| S026 | 2019-01-09 | 30-day Notice |
| S025 | 2018-12-26 | Real-time Process |
| S024 | ||
| S023 | 2018-12-11 | 30-day Notice |
| S022 | 2018-10-30 | Special (immediate Track) |
| S021 | 2018-10-19 | 30-day Notice |
| S020 | 2018-08-20 | Normal 180 Day Track |
| S019 | 2018-08-15 | 30-day Notice |
| S018 | ||
| S017 | 2018-07-25 | Special (immediate Track) |
| S016 | 2018-07-17 | 30-day Notice |
| S015 | 2018-07-02 | 30-day Notice |
| S014 | 2018-06-18 | 30-day Notice |
| S013 | 2018-06-01 | Real-time Process |
| S012 | 2018-05-24 | 30-day Notice |
| S011 | 2018-05-16 | 30-day Notice |
| S010 | 2018-05-16 | 30-day Notice |
| S009 | 2018-05-07 | 30-day Notice |
| S008 | 2018-05-07 | 30-day Notice |
| S007 | 2018-05-02 | 30-day Notice |
| S006 | 2018-04-20 | Special (immediate Track) |
| S005 | 2018-04-18 | Normal 180 Day Track No User Fee |
| S004 | 2018-04-16 | 30-day Notice |
| S003 | 2018-03-12 | 30-day Notice |
| S002 | 2018-02-01 | Normal 180 Day Track |
| S001 | 2018-01-22 | Normal 180 Day Track No User Fee |