PMA P010047S053
- Device
- PROGEL Pleural Air Leak Sealant (PALS)
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S053
- Product code
- NBE
- Decision date
- 2018-02-01
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Change to the acceptance testing of the outer pouch used to package the extended tip accessory
Current openFDA PMA Record#
- Device
- PROGEL Pleural Air Leak Sealant (PALS)
- Applicant
- Neomend, Inc.
- PMA number
- P010047
- Supplement
- S053
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2018-02-01
- Decision code
- OK30
- Date received
- 2018-01-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the acceptance testing of the outer pouch used to package the extended tip accessory