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St Jude Medical

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories7
Latest FDA decision2026-08-07
TypeNumberDevice NameCodeDateActions
PMA P960016 Cardiac ablation percutaneous catheterLPB2026-08-07 View
PMA P130026 Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillationOAE2026-08-07 View
510(k) K181382 GuardianTM Burr Hole Cover SystemGXR2018-07-20 View
510(k) K172396 EnSite Velocity Cardiac Mapping System v5.2DQK2018-04-23 View
510(k) K173232 myMerlin(TM) Mobile Application Model APP1001MXC2017-11-02 View
510(k) K160218 AutoMark ModuleDQK2016-12-13 View
510(k) K160210 EnSite Precision Cardiac Mapping System v2.0DQK2016-12-13 View
510(k) K160335 Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi DDRF2016-12-13 View
510(k) K162643 MediGuide Technology SystemDQK2016-12-13 View
510(k) K161873 Pacel Flow Directed Pacing CatheterLDF2016-11-22 View
510(k) K160187 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0DQK2016-10-21 View
510(k) K160186 EnSite Velocity Surface Electrode KitDQK2016-10-07 View
510(k) K152342 Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverGXR2016-06-09 View
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