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# FDA Denies Petition to Probe Edwards Lifesciences Marketing
- URL: https://www.fdaweb.com/fda-denies-petition-to-probe-edwards-lifesciences-marketing/
- Published: 2020-05-27T12:00:00.000Z
- Updated: 2026-09-14T16:16:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146868

FDA has denied an 11/27/17 petition submitted by **S. Albert Edwards**, a Lincolnshire, IL, pharmacist, asking that the agency investigate Edwards Lifesciences’ marketing of its Myxo ET Logix 5100 annuloplasty ring between 2007 and 2009 without agency 510(k) clearance or PMA approval. The denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-6663-0014&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says FDA interprets the petition to be a request for the agency to render an opinion on whether the company’s actions complied with the law and to take enforcement action as appropriate.

FDA explains that since it has sole responsibility for determining whether enforcement action should be taken and such requests are not appropriate in a citizen petition, it is denying the petition.

The denial letter reviews the steps FDA took after learning that Edwards had been marketing its device with no record of agency clearance and the steps the company took to resolve the issue.

“Although the Myxo ET Logix device was implanted in some patients at a time when the device had not been cleared by FDA,” the letter says, “based on the information provided in the 510(k), we concluded that the device met the standards for safety and effectiveness applicable to this Class 2 device and, as such, the device was substantially equivalent to other legally marketed annuloplasty rings. The agency, therefore, assessed that patients in whom the Myxo ET Logix had already been implanted were not placed at risk.”