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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSPINAL CORD STIMULATION SYSTEMS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS175
Date Received12/21/2010
Decision Date01/20/2011
Product Code LGW 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD NEW PRECAUTIONS REQUIRED FOR COMPLIANCE WITH APPLICABLE PORTIONS OF THE ¿IEC 60601-1 STANDARD FOR MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE.¿
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