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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 NumberP790005
Supplement NumberS039
Date Received10/17/1996
Decision Date07/17/1997
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Model ST-72 Implant Tester for use with the SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R)-2T, SpF(R)-4T, SpF(R)-XL, and the SpF(R)-XL II) and the OsteoGen(TM) Implantable Spinal Fusion Stimulator product line.