|
Device | SURGIFOAM HEMOSTATIC MATRIX KIT |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | Ferrosan Meidcal Devices A/S Sydmarken 5 Soeborg 08876 |
PMA Number | P990004 |
Supplement Number | S017 |
Date Received | 03/02/2010 |
Decision Date | 05/31/2011 |
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 CHANGES TO THE RECONSTITUTION OF METHOD FOR THE THROMBIN COMPONENT AND MODIFIED THE METHOD OF MIXING WITH THE POWDERED GELATIN COMPONENT. |