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Device | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR AND AVITENE ULTRAFOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) |
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 | S020 |
Date Received | 06/11/2003 |
Decision Date | 07/11/2003 |
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 THE PROCEDURE FOR RECORDING TEMPERATURES DURING THE DRY HEAT STERILIZATION PROCESS OF THE AVITENE PRODUCTS. |