510(k) K070847

TRIAL CABLE, 3009 by Advanced Neuromodulation Systems — Product Code GZB

K070847 is an FDA 510(k) premarket notification submitted by Advanced Neuromodulation Systems for the device "TRIAL CABLE, 3009". The FDA issued a decision of Substantially Equivalent on April 11, 2007. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Advanced Neuromodulation Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2007
Date Received
March 28, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5880
Review Panel
NE
Submission Type