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.
| Device | NFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | Intera Oncology |
| Date Received | 1989-06-12 |
| Decision Date | 1989-10-18 |
| PMA | P800036 |
| Supplement | S021 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Intera Oncology 65 William Street suite 2000 wellesley, MA 02481 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800036 | Original Filing | |
| S041 | 2020-01-09 | Normal 180 Day Track No User Fee |
| S040 | 2017-06-08 | 30-day Notice |
| S039 | 2016-08-02 | 30-day Notice |
| S038 | 2014-06-27 | Normal 180 Day Track No User Fee |
| S037 | 2010-11-24 | 30-day Notice |
| S036 | 2006-04-21 | Normal 180 Day Track No User Fee |
| S035 | 1997-10-21 | Normal 180 Day Track |
| S034 | 1997-09-04 | Normal 180 Day Track |
| S033 | ||
| S032 | 1995-07-12 | Normal 180 Day Track |
| S031 | 1994-03-08 | Normal 180 Day Track |
| S030 | 1993-12-29 | Normal 180 Day Track |
| S029 | 1992-05-18 | Normal 180 Day Track |
| S028 | ||
| S027 | ||
| S026 | ||
| S025 | 1990-06-19 | Normal 180 Day Track |
| S024 | 1990-05-29 | Normal 180 Day Track |
| S023 | ||
| S022 | ||
| S021 | 1989-06-12 | Normal 180 Day Track |
| S020 | ||
| S019 | 1989-01-23 | Normal 180 Day Track |
| S018 | 1988-12-28 | Normal 180 Day Track |
| S017 | ||
| S016 | 1987-11-17 | Normal 180 Day Track |
| S015 | 1987-09-16 | Normal 180 Day Track |
| S014 | ||
| S013 | 1985-12-10 | Panel Track |
| S012 | 1984-09-12 | |
| S011 | 1984-09-20 | |
| S010 | ||
| S009 | 1984-05-07 | |
| S008 | 1984-05-03 | |
| S007 | 1984-01-31 | |
| S006 | 1983-08-26 | |
| S005 | 1983-06-22 | |
| S004 | 1983-02-22 | |
| S003 | 1983-02-22 | |
| S002 | 1982-07-12 | |
| S001 | 1982-03-10 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 10886704044093 | P800036 | 000 |
| 10886704044109 | P800036 | 024 |
| 10886704078845 | P800036 | 024 |
| 10886704044086 | P800036 | 037 |