PMA P030039S023

Device
Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator
Applicant
Baxter Bio Science
PMA number
P030039
Supplement
S023
Product code
NBE
Decision date
2018-07-26
Classification
Sealant, Polymerizing
Generic name
Sealant, polymerizing
Approval order statement
Approval for implementing a new sterilization chamber and cycle for the Coseal Spray Set.
Summary
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Current openFDA PMA Record#

Device
Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator
Applicant
Baxter Bio Science
PMA number
P030039
Supplement
S023
Product code
NBE
Generic name
Sealant, polymerizing
Decision date
2018-07-26
Decision code
APPR
Date received
2018-05-03
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for implementing a new sterilization chamber and cycle for the Coseal Spray Set.