PMA P030039S025
- Device
- Coseal Surgical Sealant
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S025
- Product code
- NBE
- Decision date
- 2020-07-16
- Generic name
- Sealant, polymerizing
- Approval order statement
- Approval for a shelf-life extension from 6 months to 12 months.
Current openFDA PMA Record#
- Device
- Coseal Surgical Sealant
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S025
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2020-07-16
- Decision code
- APPR
- Date received
- 2020-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a shelf-life extension from 6 months to 12 months.