Regulatory Clearance

Regulatory Clearance. Means, with respect to a particular Breast Implant Product listed on Exhibit A-1 (i.e., for all shapes, sizes and SKUs on such Exhibit A-1), that such Product has been determined to be a Class III medical device and has received pre-market approval from the FDA and all other applicable Government Regulatory Authorities in the United States, where such approvals are necessary to market such Product in the United States.