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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 SYSTEM (GENESIS, ECO-C)IPG'S ; GENESIS, ECO, PROTEGE, PRODIGY) PATIENT PROGRAMMERS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS119
Date Received06/13/2016
Decision Date06/28/2016
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to the material used for the printed circuit board for the Genesic, Eon-C, Libra, and Libra XP Implantable Pulse Generators (IPGs), the Genesis and Eon/Protégé/Prodigy Patient Programmers, and the Libra and Brio Clinician Programmers.
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