PMA P010047S065
- Device
- PROGEL Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- Product code
- NBE
- Decision date
- 2022-02-09
- Generic name
- Sealant, polymerizing
- Approval order statement
- Approval for labeling changes.
Current openFDA PMA Record#
- Device
- PROGEL Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S065
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2022-02-09
- Decision code
- APPR
- Date received
- 2021-03-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling changes.