FDA grants Breakthrough Device Designation to Teleflex's Freesolve RMS for PCI

Teleflex announced the FDA has granted Breakthrough Device Designation to its Freesolve Resorbable Magnesium Scaffold for percutaneous coronary intervention. The device is being evaluated in the BIOMAG-III Pivotal Trial, designed to support a future FDA Premarket Approval application.

Detected & updated continuously · Source: Nebula

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Teleflex IncorporatedU.S. Food and Drug Administration

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