|
Device | AVITENE ULTRA FOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) 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 | S017 |
Date Received | 12/14/2000 |
Decision Date | 07/11/2001 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE SLURRY PREPARATION AND LYOPHILIZATION PROCESS AND ADJUSTMENTS TO THE PRODUCT SPECIFICATIONS RESULTING FROM THESE MANUFACTURING CHANGES. |