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 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P790002 |
Supplement Number | S019 |
Date Received | 06/24/1998 |
Decision Date | 07/27/1998 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revision of the indications and usage section of the labeling for Models 1200, 1020-S, 1026, and 101, to include the definition of nonunion recommended by the Orthopedic and Rehabilitation Devices Panel on April 28, 1998 and required per FDA's letter dated June 3, 1998 (i.e., "nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing"). |
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