Obalon Therapeutics gets approval of PMA-S application for Obalon Touch

Obalon Therapeutics announced approval of a premarket approval supplement, or PMA-S, application for the Obalon Touch Inflation System from the FDA. The Obalon Touch Inflation System is an automated system utilized to inflate the Obalon Balloon. The Obalon Touch is intended to be commercialized in combination with the Obalon Navigation System, which is designed to eliminate the need for X-ray imaging during balloon placement. A PMA-S application for the Obalon Navigation System was filed with the FDA in Q3 and is pending a decision by the FDA.
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