PMA P030039
- Device
- Coseal Applicator Tips
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S027
- Product code
- NBE
- Decision date
- 2025-12-18
- Generic name
- Sealant, polymerizing
- Approval order statement
- a supplier manufacturing site change of the Coseal Applicator Tips nonsterile sub-assemblies
Current openFDA PMA Record#
- Device
- Coseal Applicator Tips
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S032
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2025-12-18
- Decision code
- OK30
- Date received
- 2025-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a supplier manufacturing site change of the Coseal Applicator Tips nonsterile sub-assemblies