|Trade Name||HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|
|Classification Name||device, thermal ablation, endometrial|
|Applicant||AMERICAN MEDICAL SYSTEMS, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the final tester of the device to better monitor test results as well as changes in the test methods used in the final tester.