Tag: PMA

endologix

Endologix submits premarket approval application to FDA Detour system

Endologix has announced the submission of a premarket approval (PMA) application requesting approval for the Detour system to the US Food and Drug Administration...

Bard gets US FDA premarket approval for Lutonix 035 DCB in...

Bard’s Lutonix 035 drug-coated balloon PTA catheter (DCB) has been granted premarket approval (PMA) by the US Food and Drug Administration (FDA) for a...