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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.
 
Trade NameEBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II
Classification Namestimulator, invasive bone growth
Generic Nameinvasive bone growth stimulator
ApplicantELECTRO-BIOLOGY, INC.
PMA NumberP850035
Supplement NumberS021
Date Received10/17/1996
Decision Date07/17/1997
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
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) -2t, spf(r)-4t, spf(r)-xl, and the spf(r)-xl ii) and the osteogen(tm) implantable spinal fusion stimulator product line.
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