Medical Device Manufacturer · US , Plano , TX

Advanced Neuromodulation Systems - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 1999

Recent clearances: SWIFT-LOCK ANCHOR, MODEL 1192, PENTA LEAD KITS, MODELS: 3227-3234, CINCH ANCHOR, MODEL 1194

25

Total

25

Cleared

0

Denied

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

25 devices

1-12 of 25

Cleared Dec 23, 2009

SWIFT-LOCK ANCHOR, MODEL 1192

Neurology · 140d

Cleared Jun 02, 2009

PENTA LEAD KITS, MODELS: 3227-3234

Neurology · 62d

Cleared Jul 18, 2008

CINCH ANCHOR, MODEL 1194

Neurology · 80d

Cleared Oct 11, 2007

WIDE SPACED QUATTRODE LEADS

Neurology · 41d

Cleared Apr 11, 2007

TRIAL CABLE, 3009

Neurology · 14d

Cleared Dec 12, 2006

TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS

Neurology · 63d

Cleared Dec 15, 2005

ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT

Neurology · 24d

Cleared Nov 22, 2005

RAPID PROGEAMMER 3.0

Neurology · 84d

Cleared Sep 26, 2005

AXXESS BUTTERFLY ANCHOR

Neurology · 24d

Cleared May 18, 2005

ANS SCS ACCESSORY KIT

Neurology · 35d

Cleared Apr 21, 2005

TRIAL CABLE RETENTION CLIP

Neurology · 41d

Cleared Mar 25, 2004

RAPID PROGRAMMER

Neurology · 17d