|
Device | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR & ULTRAFOAM CAST SPONGE/(MCH) ULTRAWRAP/(MCH0 SYRINGEAVITENE |
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 | S025 |
Date Received | 09/02/2011 |
Decision Date | 09/29/2011 |
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 CHANGES TO QUALITY CONTROL TESTING FOR INCOMING RAW MATERIAL (BOVINE CORIUM) AND MODIFICATION TO FINISHED GOODS TESTING. |