Medical Device Manufacturer · US , Plano , TX

Advanced Neuromodulation Systems - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 1999
25
Total
25
Cleared
0
Denied

FDA 510(k) Regulatory Record - Advanced Neuromodulation Systems Neurology

25 devices
1-25 of 25
Cleared Dec 23, 2009
SWIFT-LOCK ANCHOR, MODEL 1192
K092371 · GZB
Neurology · 140d
Cleared Jun 02, 2009
PENTA LEAD KITS, MODELS: 3227-3234
K090907 · GZB
Neurology · 62d
Cleared Jul 18, 2008
CINCH ANCHOR, MODEL 1194
K081208 · GZB
Neurology · 80d
Cleared Oct 11, 2007
WIDE SPACED QUATTRODE LEADS
K072462 · GZB
Neurology · 41d
Cleared Apr 11, 2007
TRIAL CABLE, 3009
K070847 · GZB
Neurology · 14d
Cleared Dec 12, 2006
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS
K063080 · GZB
Neurology · 63d
Cleared Dec 15, 2005
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
K053250 · GZB
Neurology · 24d
Cleared Nov 22, 2005
RAPID PROGEAMMER 3.0
K052374 · GZB
Neurology · 84d
Cleared Sep 26, 2005
AXXESS BUTTERFLY ANCHOR
K052418 · GZB
Neurology · 24d
Cleared May 18, 2005
ANS SCS ACCESSORY KIT
K050922 · GZB
Neurology · 35d
Cleared Apr 21, 2005
TRIAL CABLE RETENTION CLIP
K050633 · GZB
Neurology · 41d
Cleared Mar 25, 2004
RAPID PROGRAMMER
K040609 · GZB
Neurology · 17d
Cleared Jan 30, 2004
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
K033757 · GZB
Neurology · 60d
Cleared Dec 04, 2003
LAMITRODE SPINAL CORD STIMULATION LEADS
K033429 · GZB
Neurology · 37d
Cleared Oct 06, 2003
MODIFICATION TO RENEW LEAD EXTENSION
K032751 · GZB
Neurology · 31d
Cleared Oct 03, 2003
ANS AXXESS PERCUTANEOUS LEAD
K032034 · GZB
Neurology · 94d
Cleared Oct 03, 2003
PLACER
K032349 · GZB
Neurology · 95d
Cleared Apr 24, 2003
A127 LEAD EXTENSION
K030461 · GZB
Neurology · 71d
Cleared Mar 28, 2003
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
K030674 · GZB
Neurology · 24d
Cleared Mar 11, 2003
RAPID PROGRAMMAR
K030118 · GZB
Neurology · 57d
Cleared Jun 06, 2002
PAINDOC
K021518 · GZB
Neurology · 27d
Cleared Jan 19, 2001
RENEW NEUROSTIMULATION SYSTEM
K000852 · GZF
Neurology · 310d
Cleared Sep 24, 1999
RENEW RECEIVER
K992946 · GZB
Neurology · 23d
Cleared Jun 24, 1999
RENEW LEAD EXTENSION
K991784 · GZB
Neurology · 30d
Cleared Jun 03, 1999
LAMITRODE LEADS
K990469 · GZB
Neurology · 107d
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