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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namestimulator, functional neuromuscular, scoliosis
Generic Namestimulator, functional neuromuscular, scoliosis
399 jefferson road
parsippany, NJ 07054
PMA NumberP820008
Date Received01/29/1982
Decision Date01/06/1983
Withdrawal Date 09/11/2007
Product Code
Docket Number 83M-0053
Notice Date 02/25/1983
Advisory Committee Physical Medicine
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005