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 | 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 Supplement NumberS001 Date Received09/30/2022 Decision Date12/28/2022 Product Code QTB Advisory Committee Anesthesiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-12-28 |
| PMA | P200044 |
| Supplement | S001 |
| Product Code | QTB |
| Advisory Committee | Anesthesiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Beyond Air, Inc. 825 East Gate Boulevard, Suite 320 garden City, NY 11530 PMA NumberP200044 Supplement NumberS001 Date Received09/30/2022 Decision Date12/28/2022 Product Code QTB Advisory Committee Anesthesiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Revised Labeling To Identify Additional Compatible Ventilators |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200044 | Original Filing | |
| S001 | 2022-09-30 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| B882900310 | 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 |
| B882800112 | P200044 | 000 |