St. Jude Medical, Cardiac Rhythm Management Divisi - FDA 510(k) Clear...
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - St. Jude Medical, Cardiac Rhythm Management Divisi Cardiovascular ✕
10 devices
Cleared
Nov 15, 2012
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
Cardiovascular
122d
Cleared
May 11, 2012
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
Cardiovascular
101d
Cleared
May 08, 2012
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
Cardiovascular
98d
Cleared
Sep 29, 2011
AGILLS PF DELIVERY SYSTEM
Cardiovascular
83d
Cleared
Jan 19, 2011
CPS DIRECT SL II SLITTABLE OUTER CATHETER
Cardiovascular
77d
Cleared
Apr 02, 2010
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
Cardiovascular
107d
Cleared
Aug 07, 2009
CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003,...
Cardiovascular
29d
Cleared
Jul 01, 2009
CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59,...
Cardiovascular
117d
Cleared
Apr 30, 2008
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
Cardiovascular
28d
Cleared
Mar 13, 2008
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
Cardiovascular
160d