PMA P010047S066
- Device
- Progel™ Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S066
- Product code
- NBE
- Decision date
- 2021-09-15
- Generic name
- Sealant, polymerizing
- Approval order statement
- Adding verification dose audit function to STERIS-RCT in Libertyville, IL.
Current openFDA PMA Record#
- Device
- Progel™ Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S066
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2021-09-15
- Decision code
- OK30
- Date received
- 2021-08-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding verification dose audit function to STERIS-RCT in Libertyville, IL.