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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFLOSEAL HEMOSTATIC MATRIX
Generic Nameabsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
Applicant
BAXTER HEALTHCARE CORP.
32650 n wilson rd
round lake, IL 60073
PMA NumberP990009
Supplement NumberS044
Date Received11/02/2016
Decision Date02/10/2017
Product Code PMX 
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the device design, material, labeling, and packaging, including: replacement of the 10 mL syringe assembly to align with the current 5 mL syringe design, removal of bowel for thrombin, removal of thrombin stickers, removal of malleable tip applicator (10 mL configuration only), removal of luer connector (10 mL configuration only), modification to the needle-free vial access device (VAD), incorporation of thrombin pouch assembly, modification of diluent container, removal of plastic component tray, modification to kit box (5 mL configuration only), and labeling modifications corresponding to the aforementioned modifications.
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