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 | S018 |
Date Received | 02/10/1997 |
Decision Date | 06/11/1997 |
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) COILETTE WHICH WILL BE USED TO DELIVERY THE APPROVED REPETITIVE PULSE BURST SIGNAL PRODUCED BY THE EBI BONE HEALING SYSTEM MODEL 1200. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI FLX COILETTE TO BE USED WITH THE EBI BONE HEALING SYSTEM MODEL 1200 WHICH IS INDICATED FOR NONUNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDARTHROSES. |
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