Device to Be Available for Immediate Commercialization; Clinical Data From 125 Patient Pivotal Trial to Be Released at the ASA International Stroke Conference in New Orleans on February 22, 2008. SAN LEANDRO, Calif.--(BUSINESS WIRE)--Penumbra, Inc. today announced the 510(k) clearance by the US Food and Drug Administration of the Penumbra System, which is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset. Penumbra will commence the immediate commercialization of the device in the United States.
