|
Device | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) |
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 | S011 |
Date Received | 07/21/1998 |
Decision Date | 08/10/1998 |
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 Requested the elimination of the in-vivo hemostasis test, a heavy metals test done at an intermediate bulk stage of Avitene MCH Flour, and the routine performance of finished product sterility testing as part of the sterilization release criteria for each lot of product sterilized. |