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# Regulatory Review Period for Edwards Aortic Bioprosthesis
- URL: https://www.fdaweb.com/regulatory-review-period-for-edwards-aortic-bioprosthesis/
- Published: 2019-09-12T12:00:00.000Z
- Updated: 2026-09-15T01:49:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144990

*Federal Register* notice: FDA has determined the regulatory review period for patent extension purposes for Edwards Lifesciences’ Pericardial Aortic Bioprosthesis, indicated for replacement of native or prosthetic aortic heart valves. The review period is 1,858 days, which includes 1,491 days that occurred during the testing phase and 367 days that occurred during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-11/pdf/2019-19600.pdf?ref=fdaweb.com).