PMA P010047S072
- Device
- PROGEL™ Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S072
- Product code
- NBE
- Decision date
- 2025-12-18
- Classification
- Anesthesiology
- Generic name
- Sealant, polymerizing
- Approval order statement
- to reduce the testing frequencies of three tests for the TRIDYNE™ Vascular Sealant and the PROGEL™ Pleural Air Leak Sealant
Current openFDA PMA Record#
- Device
- PROGEL™ Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S072
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2025-12-18
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to reduce the testing frequencies of three tests for the TRIDYNE™ Vascular Sealant and the PROGEL™ Pleural Air Leak Sealant