Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

St. Jude Medical, Cardiac Rhythm Management Divisi

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K122090 SJM CONFIRM IMPLANTABLE CARDIAC MONITORMXC2012-11-15 View
510(k) K120296 CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETERDQY2012-05-11 View
510(k) K120298 CPS EXCEL MEDIGUIDE ENABLED GUIDEWIREDQX2012-05-08 View
510(k) K111943 AGILLS PF DELIVERY SYSTEMDYB2011-09-29 View
510(k) K103250 CPS DIRECT SL II SLITTABLE OUTER CATHETERDQY2011-01-19 View
510(k) K093858 PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053ADSA2010-04-02 View
510(k) K092075 CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005DQY2009-08-07 View
510(k) K090613 CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2DQY2009-07-01 View
510(k) K080924 MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151DRB2008-04-30 View
510(k) K072864 ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEMDRB2008-03-13 View
↑