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. |
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Device | EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850035 |
Supplement Number | S020 |
Date Received | 07/19/1996 |
Decision Date | 08/20/1996 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 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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