Medtronic Neuromodulation Business Gets FDA Warning Letter

Medtronic Inc.’s (MDT) business for neuromodulation devices recently received a Food and Drug Administration warning letter related mainly to the company’s processes for handling complaints, the medical-device maker disclosed Tuesday.

“We are working with the FDA to quickly resolve the issues,” and do not expect a material impact on financial results, Chief Financial Officer Gary Ellis said on a conference call.

The FDA issues warning letters when it finds certain issues it wants companies to fix. The agency can block approval for new products that relate to these problems until the warning letters are lifted.

Medtronic’s neuromodulation business includes pacemaker-like devices that stimulate the brain to treat conditions like Parkinson’s disease, spinal-cord stimulators for chronic pain and other products. The business accounted for about 10% of Medtronic’s $4 billion in total sales in the recently concluded fiscal first quarter.

The Minneapolis-based company reported quarterly results that met Wall Street expectations while backing its fiscal-year earnings guidance. Shares were down 1.5% to $40.84 in premarket trading.

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Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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