PMA P030039S026
- Device
- Coseal Surgical Sealant
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S026
- Product code
- NBE
- Decision date
- 2021-07-15
- Generic name
- Sealant, polymerizing
- Approval order statement
- Approval for implementation of the BD Sterifill Advanced Syringe as a replacement for the previously used BD Sterifill.
Current openFDA PMA Record#
- Device
- Coseal Surgical Sealant
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S026
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2021-07-15
- Decision code
- APPR
- Date received
- 2021-04-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for implementation of the BD Sterifill Advanced Syringe as a replacement for the previously used BD Sterifill.