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Device | FLOSEAL NT HEMOSTATIC MATRIX |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD ROUND LAKE, IL 60073 |
PMA Number | P990009 |
Supplement Number | S014 |
Date Received | 04/29/2003 |
Decision Date | 07/10/2003 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE TRADE NAME FOR THE APPROVED KIT CONFIGURATION THAT DOES NOT CONTAIN A THROMBIN COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLOSEAL NT HEMOSTATIC MATRIX AND IS INDICATED FOR USE IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL. |