Approval for the addition of a catheter revision kit for use with the subject system. The device, as modified, will be marketed under the trade name prometra programmable implantable pump system and is indicated for intrathecal infusion of infumorph (preservative-free morphine sulfate) or preservative-free sterile 0. 9% saline solution (sodium chloride injection, usp).
| Device | PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | FLOWONIX MEDICAL, INC. |
| Date Received | 2013-08-09 |
| Decision Date | 2014-02-04 |
| PMA | P080012 |
| Supplement | S019 |
| 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 | No |
| Applicant Address | FLOWONIX MEDICAL, INC. 500 International Drive suite 200 mt.olive, NJ 07828 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080012 | | Original Filing |
| S072 |
2022-03-30 |
Special (immediate Track) |
| S071 | | |
| S070 | | |
| S069 |
2020-12-01 |
Real-time Process |
| S068 | | |
| S067 |
2020-07-31 |
Real-time Process |
| S066 | | |
| S065 |
2020-02-20 |
30-day Notice |
| S064 |
2019-12-27 |
Special (immediate Track) |
| S063 | | |
| S062 |
2019-08-16 |
Real-time Process |
| S061 | | |
| S060 |
2019-07-25 |
Real-time Process |
| S059 |
2019-07-16 |
30-day Notice |
| S058 |
2019-05-09 |
Real-time Process |
| S057 | | |
| S056 | | |
| S055 |
2019-02-04 |
30-day Notice |
| S054 | | |
| S053 |
2018-11-19 |
30-day Notice |
| S052 | | |
| S051 |
2018-05-21 |
Real-time Process |
| S050 |
2018-02-06 |
Normal 180 Day Track |
| S049 | | |
| S048 | | |
| S047 |
2017-09-19 |
Real-time Process |
| S046 |
2017-06-16 |
Real-time Process |
| S045 |
2017-06-08 |
Normal 180 Day Track No User Fee |
| S044 |
2017-05-31 |
Special (immediate Track) |
| S043 |
2017-05-10 |
30-day Notice |
| S042 |
2017-05-03 |
Real-time Process |
| S041 |
2017-05-01 |
Special (immediate Track) |
| S040 |
2017-04-12 |
Normal 180 Day Track |
| S039 |
2017-02-28 |
Special (immediate Track) |
| S038 | | |
| S037 |
2016-09-20 |
Real-time Process |
| S036 |
2016-09-16 |
135 Review Track For 30-day Notice |
| S035 |
2016-08-05 |
30-day Notice |
| S034 | | |
| S033 |
2016-02-26 |
Real-time Process |
| S032 |
2015-10-26 |
30-day Notice |
| S031 |
2015-10-20 |
Normal 180 Day Track No User Fee |
| S030 |
2015-10-13 |
Real-time Process |
| S029 |
2015-06-04 |
Real-time Process |
| S028 |
2015-05-18 |
Normal 180 Day Track No User Fee |
| S027 | | |
| S026 | | |
| S025 |
2015-03-09 |
30-day Notice |
| S024 |
2014-11-17 |
Real-time Process |
| S023 |
2014-09-15 |
Normal 180 Day Track |
| S022 |
2014-06-30 |
Normal 180 Day Track |
| S021 |
2014-04-28 |
Normal 180 Day Track |
| S020 |
2014-04-22 |
30-day Notice |
| S019 |
2013-08-09 |
Normal 180 Day Track |
| S018 |
2013-06-04 |
30-day Notice |
| S017 |
2013-05-03 |
Special (immediate Track) |
| S016 |
2013-04-05 |
Real-time Process |
| S015 | | |
| S014 |
2013-03-12 |
30-day Notice |
| S013 |
2013-03-04 |
Real-time Process |
| S012 |
2013-02-01 |
Normal 180 Day Track No User Fee |
| S011 |
2013-01-24 |
Real-time Process |
| S010 |
2013-01-08 |
30-day Notice |
| S009 |
2012-10-10 |
30-day Notice |
| S008 | | |
| S007 |
2012-08-17 |
30-day Notice |
| S006 |
2012-08-16 |
30-day Notice |
| S005 | | |
| S004 |
2012-04-20 |
Real-time Process |
| S003 |
2012-03-06 |
Normal 180 Day Track No User Fee |
| S002 |
2012-03-06 |
Normal 180 Day Track No User Fee |
| S001 |
2012-03-06 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices