FDA Premarket Approval (PMA)
Full FDA safety + effectiveness review for high-risk or novel medical devices. Rarer than 510(k) in imaging — but Hologic Selenia Dimensions 3D tomosynthesis is a notable PMA example (2011).
Why it matters to buyers
PMA indicates a device went through the most rigorous FDA pathway. Clinical study data + manufacturing inspection required. Significantly longer + more expensive than 510(k).