LungFit® PH

FDA Premarket Approval P200044 S001

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.

Pre-market Approval Supplement Details

DeviceLungFit® PH
Generic NameNitric Oxide Generator And Delivery System
ApplicantBeyond 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 Received2022-09-30
Decision Date2022-12-28
PMAP200044
SupplementS001
Product CodeQTB 
Advisory CommitteeAnesthesiology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressBeyond 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

Supplemental Filings

Supplement NumberDateSupplement Type
P200044Original Filing
S001 2022-09-30 Real-time Process

NIH GUDID Devices

Device IDPMASupp
B882900310 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
B882900020 P200044 000

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