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Device | EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850035 |
Supplement Number | S023 |
Date Received | 04/09/1998 |
Decision Date | 05/01/1998 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
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. |