Approval for a hardware change to the patient therapy controller (catalog no. 12860) that includes an updated bluetooth chip and removal of redundant circuitry in the battery protection circuit. This submission also requests an update to the device software (version 1. 02) to accommodate the change in hardware.
| Device | PROMETRA PATIENT THERAPY CONTROLLER |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | FLOWONIX MEDICAL, INC. |
| Date Received | 2016-09-16 |
| Decision Date | 2017-03-31 |
| PMA | P080012 |
| Supplement | S036 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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