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Advanced Neuromodulation Systems Inc.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
25
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0025-2013Class IIThe Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system tSeptember 4, 2012
Z-0894-2013Class IIAdvanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model March 28, 2012
Z-1983-2012Class IIEon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the maDecember 19, 2011
Z-2281-2012Class IIThe Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-programDecember 19, 2011
Z-2280-2012Class IIEon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 eDecember 19, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K092371SWIFT-LOCK ANCHOR, MODEL 1192December 23, 2009
K090907PENTA LEAD KITS, MODELS: 3227-3234June 2, 2009
K081208CINCH ANCHOR, MODEL 1194July 18, 2008
K072462WIDE SPACED QUATTRODE LEADSOctober 11, 2007
K070847TRIAL CABLE, 3009April 11, 2007
K063080TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADSDecember 12, 2006
K053250ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KITDecember 15, 2005
K052374RAPID PROGEAMMER 3.0November 22, 2005
K052418AXXESS BUTTERFLY ANCHORSeptember 26, 2005
K050922ANS SCS ACCESSORY KITMay 18, 2005
K050633TRIAL CABLE RETENTION CLIPApril 21, 2005
K040609RAPID PROGRAMMERMarch 25, 2004
K033757MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEMJanuary 30, 2004
K033429LAMITRODE SPINAL CORD STIMULATION LEADSDecember 4, 2003
K032751MODIFICATION TO RENEW LEAD EXTENSIONOctober 6, 2003
K032349PLACEROctober 3, 2003
K032034ANS AXXESS PERCUTANEOUS LEADOctober 3, 2003
K030461A127 LEAD EXTENSIONApril 24, 2003
K030674MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEADMarch 28, 2003
K030118RAPID PROGRAMMARMarch 11, 2003