High-Tech Heart Valves Deserve Full PMA Review: FDA AdvisorsHigh-Tech Heart Valves Deserve Full PMA Review: FDA Advisors

There was no official vote, nor was one called for. The panel mulled whether "more-than-minimally-manipulated" allograft valves in general needed more than "substantial equivalence" for approval. Heartwire
Source: Medscape Cardiology Headlines - Category: Cardiology Tags: Cardiology News Source Type: news