| Device | LungFit PH |
| Generic Name | Nitric Oxide Generator And Delivery System |
| Applicant | Beyond Air, Inc.825 East Gate Boulevard, Suite 320garden City, NY 11530 PMA NumberP200044 Date Received11/17/2020 Decision Date06/28/2022 Product Code QTB Advisory Committee Anesthesiology Expedited Review Granted? No |
| Date Received | 2020-11-17 |
| Decision Date | 2022-06-28 |
| PMA | P200044 |
| Supplement | S |
| Product Code | QTB |
| Advisory Committee | Anesthesiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Beyond Air, Inc. 825 East Gate Boulevard, Suite 320 garden City, NY 11530 PMA NumberP200044 Date Received11/17/2020 Decision Date06/28/2022 Product Code QTB Advisory Committee Anesthesiology Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For The LungFit® PH. The Device Is Indicated To Deliver Nitric Oxide (NO), A Vasodilator, Generated By The Device Into The Inspiratory Limb Of The Patient Breathing Circuit Of A Ventilator In A Way That Provides A Constant Concentration Of NO, As Set By The User, To The Patient Throughout The Inspired Breath. The LungFit® PH Provides Continuous Integrated Monitoring Of Inspired Oxygen (O2), Nitrogen Dioxide (NO2) And NO, And A Comprehensive Alarm System. The LungFit® PH Includes An Integrated Backup NO Delivery System That Is A Completely Independent Backup NO Generating System; It Has Its Own NO Generator And Gas Flow Delivery System. The Backup Flow Is Delivered At 1 L/min At 220ppm NO To Either A Ventilator Circuit Or To A Bagging System, Depending Upon The User Selected Setting. The NO Generated By The LungFit® PH System Is Indicated To Improve Oxygenation And Reduce The Need For Extracorporeal Membrane Oxygenation In Term And Near-term (>34 Weeks Gestation) Neonates With Hypoxic Respiratory Failure Associated With Clinical Or Echocardiographic Evidence Of Pulmonary Hypertension In Conjunction With Ventilatory Support And Other Appropriate Agents. Supplements: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200044 | Original Filing | |
| S001 | 2022-09-30 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| B882900310 | P200044 | 000 |
| B882800120 | P200044 | 000 |
| B882800112 | P200044 | 000 |
| B882900020 | P200044 | 000 |
| B882900051 | P200044 | 000 |
| B882900061 | P200044 | 000 |
| B882900071 | P200044 | 000 |
| B882900081 | P200044 | 000 |
| B882900091 | P200044 | 000 |
| B882900141 | P200044 | 000 |
| B882900151 | P200044 | 000 |
| B882900161 | P200044 | 000 |
| B882900171 | P200044 | 000 |
| B882800130 | P200044 | 000 |