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# Cardiologist Sends Affidavit to Hahn
- URL: https://www.fdaweb.com/cardiologist-sends-affidavit-to-hahn/
- Published: 2020-01-23T12:00:00.000Z
- Updated: 2026-09-14T15:59:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145915

Wisconsin cardiologist **Nalini Rajamannan**, medical director of the Most Sacred Heart of Jesus Cardiology and Vascular Institute, has sent FDA commissioner **Stephen Hahn** an [affidavit](https://www.marketwatch.com/press-release/newly-minted-fda-commissioner-dr-stephen-hahn-receives-minneapolis-fda-affidavit-from-dr-nalini-rajamannan-regarding-fda-design-control-study-using-a-non-exempt-medical-device-2020-01-22?ref=fdaweb.com) arising from her years of effort to get the agency to release information to 667 patients who were implanted with the Edward Lifesciences Myxo ETlogix non-exempt medical device. Rajamannan says that although FDA determined that the company was distributing the device without agency approval, it has no plans to release any information to patients.