Sterilization. The Sterilization strategy is to be 3X EtO capable, which will be the same as current marketed devices (self expandable stents). Previous Cordis validations will be leveraged for sterilization. DV/PQ units for both product and its packaging for the 36 new Carotid Stent Delivery System catalogs - 57cm length will be subjected to three EtO sterilization cycles. See License Agreement for Complaint Handling and FAL. For detailed timeline see Attachment 1.
Appears in 3 contracts
Sources: Supply Agreement (Silk Road Medical Inc), Supply Agreement (Silk Road Medical Inc), Supply Agreement (Silk Road Medical Inc)