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Device | Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | C.R. Bard, Inc. 160 NEW BOSTON STREET WOBURN, MA 01801 |
PMA Number | P800002 |
Supplement Number | S027 |
Date Received | 08/03/2020 |
Decision Date | 04/01/2022 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the replacement of current qualitative in process heavy metals testing with a quantitative test and removal of in process testing of total ash content |