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-MODEL 1026 |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P790002 |
Supplement Number | S021 |
Date Received | 11/30/1999 |
Decision Date | 12/29/1999 |
Product Code |
LOF |
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 Seven modifications to the Model 1026. Addition of components to the printed wiring board, addition of a ferrite sleeve, change in the control unit and labeling changes. |
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