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. |
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Device | FLOSEAL HEMOSTATIC MATRIX |
Generic Name | Absorbable collagen hemostatic agent with thrombin |
Regulation Number | 878.4490 |
Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD ROUND LAKE, IL 60073 |
PMA Number | P990009 |
Supplement Number | S044 |
Date Received | 11/02/2016 |
Decision Date | 02/10/2017 |
Product Code |
PMX |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 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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