|
Device | SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P. |
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 | S021 |
Date Received | 02/04/2011 |
Decision Date | 03/02/2011 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN PACKAGING LINE EQUIPMENT. |