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510(k) K123299

MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS by St. Jude Medical Neuromodulation — Product Code GZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2013
Date Received
October 23, 2012
Clearance Type
Traditional
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

Other clearances by St. Jude Medical Neuromodulation

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