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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
399 jefferson road
parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS022
Date Received04/08/1997
Decision Date04/22/1997
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the spf-xl iib implantable spinal fusion stimulator which is a modification of the spf-xl ii implantable spinal fusion stimulator. The spf-xl iib implantable spinal fusion stimulator has a smaller generator case than the spf-xl ii implantalble spinal fusion stimulator. The device, as modified, will be marketed under the trade name the spf-xl iib implantable spinal fusion stimulator and is indicated for use as a spinal fusion adjunct to increase the probability of fusion success in 3 or more levels.