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# Regulatory Review Period Determined for Sorin Heart Valve
- URL: https://www.fdaweb.com/regulatory-review-period-determined-for-sorin-heart-valve/
- Published: 2018-01-22T12:00:00.000Z
- Updated: 2026-09-14T23:15:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140559

*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for Sorin Group Italia’s Perceval Sutureless Heart Valve was 1,003 days. Of this time, 694 days occurred during the testing phase and 309 days occurred during the approval phase. The product is indicated for use when replacing diseased, damaged, or malfunctioning native or prosthetic aortic valves. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-01-22/pdf/2018-00995.pdf?ref=fdaweb.com).