PMA P030039S028

Device
Coseal Surgical Sealant, Coseal Spray Set
Applicant
Baxter Bio Science
PMA number
P030039
Supplement
S028
Product code
NBE
Decision date
2023-02-23
Classification
Cardiovascular
Generic name
Sealant, polymerizing
Approval order statement
Change in location of residuals testing.

Current openFDA PMA Record#

Device
Coseal Surgical Sealant, Coseal Spray Set
Applicant
Baxter Bio Science
PMA number
P030039
Supplement
S028
Product code
NBE
Generic name
Sealant, polymerizing
Decision date
2023-02-23
Decision code
OK30
Date received
2023-01-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in location of residuals testing.