PMA P010047S067
- Device
- PROGEL Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S067
- Product code
- NBE
- Decision date
- 2022-09-06
- Generic name
- Sealant, polymerizing
- Approval order statement
- Relocation of the Glass Cartridge Syringe Manufacturing site.
Current openFDA PMA Record#
- Device
- PROGEL Pleural Air Leak Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S067
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2022-09-06
- Decision code
- OK30
- Date received
- 2022-08-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the Glass Cartridge Syringe Manufacturing site.