Posted AT 8:17 AM EST on 20/12/07
Ondine reports progress in FDA submission for Periowave
VANCOUVER — Ondine Biopharma Corp. says the U.S. Food and Drug Administration has announced pre-market classification for its submission on the Periowave photo-disinfection system for dentistry.
An FDA branch classified the device as Class 3 (pre-market approval), an automatic designation since no substantially equivalent system has been sold previously.
The regulatory pathway is subject to continued evaluation.
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