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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.
 
DeviceSCOLITRON(TM) STIMULATOR
Generic NameStimulator, functional neuromuscular, scoliosis
ApplicantEbi, L.P.
399 Jefferson Rd.
Parsippany, NJ 07054
PMA NumberP820008
Supplement NumberS005
Date Received01/16/1987
Decision Date04/02/1987
Withdrawal Date09/11/2007
Product Code LWB 
Advisory Committee Physical Medicine
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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