Medtech approvals: FDA releases January 2017 PMA approvals

Summary of PMA Originals & Supplements Approved Originals: 4 Supplements: 40 Submission Number Date Final Decision Review Track Trade Name Appl/Spr Name Approval Order Statement P140033 01/31/2017 PMAO – PMA Original ASSURITY MRI AND ENDURITY MRI PACEMAKERS, TENDRIL MRI LEAD, MRI ACTIVATOR, MERLIN PCS PROGRAMER SOFTWARE ST. JUDE MEDICAL, INC. Approval for the MR Conditional Pacemaker System (which includes the Assurity MRI (Models PM 1272, PM 2272) and Endurity MRI (Models PM 1172, PM 2172) pacemakers, Tendril MRI Lead (Model LPA 1200M), MRI Activator (Model EX4000), Merlin PCS Programmer Software (Model 3330 v 22.1.1), Merlin.net MN5000 7.4d, and Merlin@home EX2000 8.2.2). Implantation of a singlechamber pulse generator or dual-chamber pulse generator is indicated for in one or more of the following permananent conditions: 1) Syncope; 2) Presyncope; 3) Fatigue; 4) Disorientation; or 5) Any combination of those symptoms MR Conditional pulse generator is safe for use in the MRI environment when used as a complete MR Conditional pacing system, and according to the instructions in the MRI Procedure Information document for the St. Jude Medical MR Conditional Pacing System. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Chronotropic incompetence has not been rigorously defined. A conservative approach, supported by the literature...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news