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 BONE HEALING SYSTEM(R) |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | EBI, LLC a Highridge Medical Company 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P790002 |
Supplement Number | S015 |
Date Received | 07/19/1994 |
Decision Date | 03/12/1998 |
Product Code |
LOF |
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 FLX(R)-S Coils (model numbers FLX 2-S, FLX 3-S, and FLX 4-S) which will be used to deliver the single repetitive pulse (SRP) signal produced by the EBI Bone Healing System(R) Model 1020-S control unit. The device, as modified, will be marketed under the trade name EBI FLX(R)-S Coils and used with the EBI Bone Healing System(R) Model 1020-S control unit which is indicated for the treatment of nonunions, failed fusions, and congenital pseudarthroses. |
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