PMA P030039S027
- Device
- Coseal Surgical Sealant; Coseal Spray Set
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S027
- Product code
- NBE
- Decision date
- 2021-10-27
- Generic name
- Sealant, polymerizing
- Approval order statement
- Several manufacturing changes to the syringe clip component of the Coseal Surgical Sealant product.
Current openFDA PMA Record#
- Device
- Coseal Surgical Sealant; Coseal Spray Set
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S027
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2021-10-27
- Decision code
- OK30
- Date received
- 2021-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Several manufacturing changes to the syringe clip component of the Coseal Surgical Sealant product.