FDA says pancreatic stents are lower-risk at Xlumena's request

Xlumena convinces U.S. healthcare regulators to downgrade pancreatic drainage stents to Class II status, lowering their risk category and level of regulatory oversight.

The FDA today issued a final order lowering the risk classification for pancreatic drainage stents at the request of device maker Xlumena.

The FDA agreed that Class II special controls are sufficient to ensure that new devices are safe and effective, taking pancreatic stents off of the more-stringent premarket approval system.

Food & Drug Administration (FDA), Xlumena

News Well, Regulatory/Clearance, 510(k), Food & Drug Administration (FDA), Pre-Market Approval (PMA), Stents

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