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 | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | DJO, LLC 1430 DECISION STREET VISTA, CA 92081-8553 |
PMA Number | P910066 |
Supplement Number | S008 |
Date Received | 12/30/1997 |
Decision Date | 06/12/1998 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the indications for use language to state "The Orthologic 1000 Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site show no visibly progressive sign s of healing"; and "The Orthologic CC Bone Growth Stimulator is indicated for the noninvasive treatment of an established nonunion acquired secondary to trauam, ecxluding vertebrae and all flate bones. A nonunion is considred to be established when the fracture site shows no visibly progressive signs of healing." |
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