Anticipated and unanticipated Clause Samples

Anticipated and unanticipated adverse device effects will be adapted from a list of approved by FDA from the previous study of the prototype device (see section 6.6). Those events will be incorporated into the Investigators Brochure, and recorded in the Case Report Forms. Serious adverse events will be reported within 72 hrs to the sponsor, local IRB, AFIRM Clinical Trials Unit and FDA IDE office.