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PMA P990009S042

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S042
Product code
PMX
Decision date
2016-11-22
Classification
Absorbable Collagen Hemostatic Agent With Thrombin
Generic name
Absorbable collagen hemostatic agent with thrombin
Approval order statement
Approval for artwork changes to the exterior of the product syringes, removal of a colorant clarifier from the syringe plunger, and addition of a black colorant to the plunger tip of the mixing syringe in order to support the addition of an alternative syringe supplier.

Current openFDA PMA Record#

Device
FLOSEAL HEMOSTATIC MATRIX
Applicant
Baxter Healthcare Corp
PMA number
P990009
Supplement
S042
Product code
PMX
Generic name
Absorbable collagen hemostatic agent with thrombin
Decision date
2016-11-22
Decision code
APPR
Date received
2016-06-02
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for artwork changes to the exterior of the product syringes, removal of a colorant clarifier from the syringe plunger, and addition of a black colorant to the plunger tip of the mixing syringe in order to support the addition of an alternative syringe supplier.