FDAnews
www.fdanews.com/articles/147462-fda-formalizes-pma-requirement-for-all-implantable-pacemakers-programmers

FDA Formalizes PMA Requirement for All Implantable Pacemakers, Programmers

June 25, 2012
Federal regulators today issued two final rules formalizing the FDA review process for new and existing implantable pacemakers and pacemaker programmers.
Mass Device