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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-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
Classification Namestimulator, invasive bone growth
Generic Nameinvasive bone growth stimulator
ApplicantELECTRO-BIOLOGY, INC.
PMA NumberP850035
Supplement NumberS023
Date Received04/09/1998
Decision Date05/01/1998
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a 4cm mesh cathode to be used with the spf-2t stimulator and a 8cm mesh cathode to be used with the spf-xl iib stimulator. The device, as modified, will be marketed under the trade names spf-2t/cm and spf-xl iib 2/dm and is indicated for the same used as the spf-2t and spf-xl iib.
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