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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.
 
DeviceSPF(R) IMPLANTABLE SPINAL FUSION STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS013
Date Received03/27/1992
Decision Date03/09/1994
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Physical Medicine
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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