Approval for mri conditional labeling changes within the instructions for use, patients guide, patient id cards which are associated with the prometra programmable pump, prometra ii programmable pump, intrathecal catheter, and catheter revision kit.
| Device | Prometra Programmable Infusion Pump System |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | FLOWONIX MEDICAL, INC. |
| Date Received | 2017-02-28 |
| Decision Date | 2017-03-30 |
| PMA | P080012 |
| Supplement | S039 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| 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