PMA P010047S063
- Device
- Progel Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- Product code
- NBE
- Decision date
- 2021-08-17
- Generic name
- Sealant, polymerizing
- Approval order statement
- Approval for replacing the 5mL sterile water vial with a 10mL vial
Current openFDA PMA Record#
- Device
- Progel Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S063
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2021-08-17
- Decision code
- APPR
- Date received
- 2020-12-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for replacing the 5mL sterile water vial with a 10mL vial