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# Aegea Vapor System Regulatory Review Period
- URL: https://www.fdaweb.com/aegea-vapor-system-regulatory-review-period/
- Published: 2019-09-11T12:00:00.000Z
- Updated: 2026-09-15T01:49:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144976

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Tsunami MedTech’s Aegea Vapor System, indicated for ablation of the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes in whom childbearing is complete. The review period is 1,381 days, which includes 1,148 days that occurred during the testing phase and 233 days during the approval phase. To view the notice, click [here](http://webmail.fdaweb.com/a/webmail.php?wsid=d9caa8725ab041408a98d28ebccedd86-9e640e35da1e97da6ede6da576aa38e0&ref=fdaweb.com).