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Does anyone know why Medtronic AEDs have a FDA shipping suspension for more than two years now?
I've read:
But more than two years later they're still not shipping. What's up?
I've read:
Physio's jockeying in the domestic AED market ground to a halt in January. The company voluntarily stopped shipping to U.S. clients after the firm and the FDA found problems related to internal documentation, management oversight and the procedural follow-through of quality documentation processes. The suspension didn't stem from device malfunctions or incidents related to patients, and no products have been recalled, the company said.
But more than two years later they're still not shipping. What's up?