ETView Medical, Ltd. Announced Filing of a 510(k) Pre-Marketing Notification Application with the US FDA for the Viva™ EB Line of Innovative Endobronchial Blockers
2/6/2012 6:22:31 AM
TEL AVIV, Israel--(BUSINESS WIRE)--ETView (TASE: ETVW) today announced that the company has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA). The Company expects feedback from the FDA during the next quarter and anticipates entering the US market with the Viva™ EB during 2012. Additional pre-market regulatory filings in Europe and Asia are anticipated during 2012.