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# Regulatory Review Period Determined for Impella 2.5 System
- URL: https://www.fdaweb.com/regulatory-review-period-determined-for-impella-2-5-system/
- Published: 2017-10-06T12:00:00.000Z
- Updated: 2026-09-14T22:54:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139803

*Federal Register* notice: FDA has determined that the regulatory review period for patent extension purposes for Abiomed Europe’s Impella 2.5 System is 3,227 days — of this, 2,858 days occurred during the testing phase and 369 days occurred during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-05/pdf/2017-21436.pdf?ref=fdaweb.com).