|
Device | AVITENE ULTRAFOAM MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 Crossings Boulevard Warwick, RI 02886 |
PMA Number | N17600 |
Supplement Number | S027 |
Date Received | 05/28/2013 |
Decision Date | 06/27/2013 |
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 REVISED LAL (ENDOTOXIN) TEST FOR THE AVITENE® ULTRAFOAM® MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE MANUFACTURED AT THE WOBURN MASSACHUSETTS SITE. |