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 changes made to the design history file and device master record of the motor component of the synchromed ii implantable system for remodulin, (model 8637p), the associated parts of the motor (i. E. Assemblies, subassemblies, components, subcomponents, and materials used in the manufacturing of the motor assembly), and the pumphead assembly material specifications.
| Device | Implantable System for Remodulin |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | Medtronic, Inc. |
| Date Received | 2018-02-01 |
| Decision Date | 2018-04-17 |
| PMA | P140032 |
| Supplement | S002 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |