PMA P030039S031
- Device
- Coseal Spray Set
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S031
- Product code
- NBE
- Decision date
- 2025-08-21
- Classification
- Cardiovascular
- Generic name
- Sealant, polymerizing
- Approval order statement
- changing the cutting of the tubing from a manual to an automated process for the COSEAL Spray Set
Current openFDA PMA Record#
- Device
- Coseal Spray Set
- Applicant
- Baxter Bio Science
- PMA number
- P030039
- Supplement
- S031
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2025-08-21
- Decision code
- OK30
- Date received
- 2025-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changing the cutting of the tubing from a manual to an automated process for the COSEAL Spray Set