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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceST. JUDE MEDICAL ADAPTER
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS083
Date Received07/10/2014
Decision Date10/15/2014
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MINOR DESIGN CHANGES TO THE SINGLE 8 EXTENSION (MODEL3383) TO INTRODUCE A NEW 8-CHANNEL ADAPTER (MODELS 2311 AND 2316) FOR SPINAL CORD STIMULATION (SCS) SYSTEMS. THE NEW 8-CHANNEL ADAPTER IS INTENDED TO CONNECT A COMPATIBLE 8-CHANNEL MEDTRONIC LEAD OR EXTENSION TO A ST. JUDE MEDICAL IMPLANTABLE PULSE GENERATOR.
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