|
Device | SURGIFOAM ABSORBABLE GELATIN POWDER |
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 | S009 |
Date Received | 12/20/2005 |
Decision Date | 02/02/2006 |
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 3 GRAM SIZE PACKAGE OF THE SURGIFOAM ABSORBABLE GELATIN POWDER. |