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Device | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB |
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 | S012 |
Date Received | 05/23/2001 |
Decision Date | 06/18/2001 |
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 ELIMINATION OF CERTAIN IN PROCESS OR FINAL DEVICE TESTS PERFORMED ON AVITENE COLLAGEN HEMOSTASIS (MCH) PRODUCTS. THIS WILL ELIMINATE TEST REDUNDANCY, WASTE AND/OR PROVIDE A MORE EFFICIENT UTILIZATION OF TEST SAMPLES SELECTED DURING THE PROCESSING OF AVITENE. |