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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K123299
Device Name MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
Applicant
St. Jude Medical Neuromodulation
6901 Preston Rd.
Plano,  TX  75024
Applicant Contact TERRINA WILDER, RAC
Correspondent
St. Jude Medical Neuromodulation
6901 Preston Rd.
Plano,  TX  75024
Correspondent Contact TERRINA WILDER, RAC
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received10/23/2012
Decision Date 01/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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