|
Device | FLOSEAL(R) MATRIX/PROCEED(TM) HEMOSTATIC SEALANT |
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 | S005 |
Date Received | 02/01/2001 |
Decision Date | 03/15/2001 |
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 | No |
Approval Order Statement APPROVAL FOR A MODIFICATION KIT CONFIGURATION WITHOUT THE THROMBIN COMPONENT. |