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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II
Classification Namestimulator, invasive bone growth
Generic Namestimulator, invasive bone growth
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP850035
Supplement NumberS020
Date Received07/19/1996
Decision Date08/20/1996
Product Code
LOE[ Registered Establishments with LOE ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
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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