|
Device | FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT |
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 | S026 |
Date Received | 04/17/2009 |
Decision Date | 05/04/2009 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR INCLUSION OF TWO ADDITIONAL PRODUCT APPLICATOR TIPS TOGETHER AS PART OF THE FLOWSEAL HEMOSTATIC MATRIX KIT OR PACKAGED INDIVIDUALLY. |