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 | Prometra Programmable Infusion Pump System |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | FLOWONIX MEDICAL, INC.500 International Drivesuite 200mt.olive, NJ 07828 PMA NumberP080012 Supplement NumberS072 Date Received03/30/2022 Decision Date04/28/2022 Product Code LKK Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-03-30 |
| Decision Date | 2022-04-28 |
| PMA | P080012 |
| Supplement | S072 |
| 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 | No |
| Applicant Address | FLOWONIX MEDICAL, INC. 500 International Drive suite 200 mt.olive, NJ 07828 PMA NumberP080012 Supplement NumberS072 Date Received03/30/2022 Decision Date04/28/2022 Product Code LKK Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement The Center For Devices And Radiological Health (CDRH) Of The Food And Drug Administration (FDA) Has Completed Its Review Of Your Premarket Approval Application (PMA) Supplement, Which Requested Labeling Updates To The Refill Kit And MRI Scan Instructions For Use. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00810335020136 | P080012 | 000 |
| 00810335020082 | P080012 | 000 |
| 00810335020099 | P080012 | 000 |
| 00810335020150 | P080012 | 000 |
| 00810335020143 | P080012 | 000 |
| 00810335020129 | P080012 | 000 |
| 00810335020105 | P080012 | 019 |
| 00810335020167 | P080012 | 021 |
| 00810335020228 | P080012 | 022 |
| 00810335020174 | P080012 | 023 |
| 00810335020181 | P080012 | 023 |
| 00810335020242 | P080012 | 049 |