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# Regulatory Review Period for Edwards Aortic Valve
- URL: https://www.fdaweb.com/regulatory-review-period-for-edwards-aortic-valve/
- Published: 2019-05-24T12:00:00.000Z
- Updated: 2026-09-15T01:28:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144187

*Federal Register* notice: FDA has determined that the regulatory review period for Edwards Lifesciences’ Edwards Intuity Elite Aortic Valve is 1,508 days, which includes 1,203 days that occurred during the testing phase and 305 days during the approval phase. The device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-24/pdf/2019-10889.pdf?ref=fdaweb.com).