FDA bids to expand RF (radiofrequency) ablation device use
This article was originally published in Clinica
The US FDA has issued guidance on catheter-based radiofrequency ablation devices so that companies can readily expand the indications for use of their existing models. The current products on the market have been approved to treat specific arrhythmias. With the guidance, the FDA hopes to encourage manufacturers to file a PMA supplemental that would allow these products to be used for all forms of arrhythmias.
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