SynchroMed II regulatory update

Medtronic submitted a PMA to FDA for its SynchroMed II implantable drug infusion system for use with Remodulin treprostinil from United Therapeutics to treat pulmonary arterial hypertension (PAH). United Therapeutics plans to submit an sNDA to FDA this month to amend Remodulin’s labeling to support use of the drug with the system. ...