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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
Classification Namestimulator, invasive bone growth
Generic Nameinvasive bone growth stimulator
ApplicantELECTRO-BIOLOGY, INC.
PMA NumberP850035
Supplement NumberS018
Date Received12/08/1995
Decision Date01/16/1996
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the patient brochure titled "answers to your questions aboutthe spf spinal fusion stimulator. " these changes include deletion of specific, unsubstnatiated claims regarding patients safety and inclusion of information regarding device explanatation and mri warning and precaution statements, as requested in our july 18, 1995, letter.
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