I recognize that the FDA has cleared the Acessa ProVu system for the indicated use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic
I am aware that insufficient data exists on which to evaluate the safety and effectiveness of the Acessa procedure in
women who plan future pregnancy. Therefore, the Acessa procedure is not recommended for women who are planning
future pregnancy. I am aware that the safety and effectiveness of the Acessa procedure has not been evaluated in women with uterine size > 14 weeks.
I am aware there is additional important information including but not limited to additional warnings and precautions in the full instructions for use, which is required to be reviewed prior to performing the procedure.
I affirm that no Acessa employee or representative has promoted, either explicitly or implicitly, the use of Acessa’s products for purposes that are inconsistent with approved labeling.
Any use of Acessa’s products that is inconsistent with distributed labeling and which I may undertake will be at my sole discretion as a licensed medical practitioner
Hospital or Practice Name