|
Device | SURGIFOAM ABSORBABLE GELATIN SPONGE |
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 | S012 |
Date Received | 06/20/2007 |
Decision Date | 12/13/2007 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF CLINICAL RESULTS TO THE PRODUCT LABELING WITH AN UPDATE TO THE DIRECTIONS FOR USE TO ALLOW USE IN ENDOSCOPIC NASAL SINUS SURGERY AND ADDITION OF A BENDABLE APPLICATOR TIP (FLEXTIP). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P. AND IS INDICATED FOR AN ADJUNCT TO HEMOSTASIS DURING SURGICAL PROCEDURES. |