Francisco Martinez Murillo - Comment

In pg 12/22, omit "who" in: Patient Tolerance for Risk: Patients "who" are willing to take the risk of having the device implanted even for a small probability of benefit because they have no other treatment options and their symptoms are severe In pgs 14 and 15/22, add "Approval/Non-Approval Considerations:" header, to the last paragraphs of Examples 2 and 3. In the spirit of transparency and to allow a better understanding of FDA's decision making process, it may be useful to add the file number reference for the different examples of Section 5.2, Examples Based on Actual FDA Benefit-Risk Determinations.