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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 NumberS020
Date Received07/19/1996
Decision Date08/20/1996
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 spf-xl ii implantable spinal fusion stimulator shich is a modification of the spf-xl implantable spinal fusion stimulator. The spf-xl implantable spinal fusion stimulator consists of 4 leads, each being 12 cm in length while the spf-xl ii will have only 2 leads, each being 24 cm in length. The device as modified, will be marketed under the trade name spf-xl ii implantable spinal fusion stimulator.
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