|Trade Name||HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM|
|Classification Name||device, thermal ablation, endometrial|
|Applicant||AMERICAN MEDICAL SYSTEMS, INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the transfer of the dewar assembly component procurement, incoming receiving and inspection, and sub-assembly activities, including machine grind and nitrogen testing, from american medical systems to joining technologies.