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FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT

FDA premarket approval P990009/S025 · decided 2010-01-07

Approval details

PMA number
P990009
Supplement
S025
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT
Generic name
Agent, absorbable hemostatic, collagen based
Applicant
Baxter Healthcare Corp
Date received
2009-02-26
Decision date
2010-01-07
Days to decision
315 days
Decision code
APPR
Product code
LMF
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Round Lake, IL
Statement
APPROVAL FOR INCLUSION OF HUMAN THROMBIN THAT HAS BEEN TREATED WITH A SECOND VIRAL INACTIVATION STEP (SOLVENT DETERGENT PROCESS) IN THE FLOSEAL HEMOSTATIC MATRIX KIT AS WELL AS APPROVAL FOR ASSOCIATED LABELING CHANGES TO REFLECT THE ADDITIONAL VIRAL INACTIVATION STEP FOR THE THROMBIN COMPONENT.

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