PMA P010047S064
- Device
- Progel Pleural Air Leak Sealant (Progel™ PALS)
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S064
- Product code
- NBE
- Decision date
- 2021-02-11
- Generic name
- Sealant, polymerizing
- Approval order statement
- Addition of an equivalent piece of testing equipment utilized in a lot release test.
Current openFDA PMA Record#
- Device
- Progel Pleural Air Leak Sealant (Progel™ PALS)
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S064
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2021-02-11
- Decision code
- OK30
- Date received
- 2021-01-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an equivalent piece of testing equipment utilized in a lot release test.