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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.
 
DeviceCORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantCordis Corp.
P.O. Box 525700
Miami, FL 33152
PMA NumberP800040
Supplement NumberS008
Date Received07/10/1986
Decision Date08/20/1986
Withdrawal Date05/12/2016
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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