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 | PHYSIO-STIM BONE GROWTH STIMULATOR |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | Orthofix, Inc. 3451 Plano Parkway Lewisville, TX 75056 |
PMA Number | P850007 |
Supplement Number | S023 |
Date Received | 07/21/1998 |
Decision Date | 08/14/1998 |
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 the elimination of daily shut down after three hours ofuse and a change int he overall device lock-up time from 270 days to 365 days. |
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