PFM Medical Receives FDA Premarket Approval (PMA) for Nit-Occlud® PDA, Transcatheter Patent Ductus Arteriosus (PDA) Occlusion Device
CARLSBAD, Calif., Aug. 22, 2013 /PRNewswire-iReach/ -- PFM Medical, a leading developer and manufacturer of innovative, minimally invasive medical devices for cardio vascular technology, vascular access, surgery, and oncology, announced today that it has received U.S. Food and Drug Administration (FDA) premarket approval for its Nit-Occlud® PDA device. Nit-Occlud® PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter less than 4 mm.
A Phase II Clinical Study was conducted with 378 subjects enrolled in 15 study centers throughout the U.S. under an Investigational Device Exemption (IDE) to establish a reasonable assurance of safety and effectiveness of the Nit-Occlud® PDA. Favorable results meeting all objective performance criteria from this clinical study were the basis for the premarket approval decision.
Founded in 1971, PFM Medical is a privately-owned, globally active, independent manufacturer, technology partner, service provider, and distributor headquartered in Cologne, Germany with offices and subsidiaries worldwide.
More information about PFM Medical can be found at www.pfmmedical.com
Media Contact: Marshall Kerr, PFM Medical, 760-758-8749, email@example.com
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SOURCE PFM Medical