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Device | Avitene 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 | S030 |
Date Received | 06/28/2018 |
Decision Date | 08/01/2018 |
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 Alternate in-process test method and test equipment (digital meter) used for % Ethanol determination during AviteneTM Microfibrillar Collagen Hemostat bulk flour production. |