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 | S021 |
Date Received | 10/17/1996 |
Decision Date | 07/17/1997 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the Model ST-72 Implant Tester for use with the SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R) -2T, SpF(R)-4T, SpF(R)-XL, and the SpF(R)-XL II) and the OsteoGen(TM) Implantable Spinal Fusion Stimulator product line. |
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