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-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 | S022 |
Date Received | 04/08/1997 |
Decision Date | 04/22/1997 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR WHICH IS A MODIFICATION OF THE SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR. THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR HAS A SMALLER GENERATOR CASE THAN THE SPF-XL II IMPLANTALBLE SPINAL FUSION STIMULATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR AND IS INDICATED FOR USE AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 3 OR MORE LEVELS. |
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