| 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 | SONIC ACCELERATED FRACTURE HEALING SYSTEM |
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| Generic Name | Stimulator, ultrasound and muscle, for use other than applying therapeutic deep |
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| Regulation Number | 890.5870 |
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| Applicant | Bioventus, LLC
4721 Emperor Blvd., Suite 100
Durham, NC 27703 |
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| PMA Number | P900009 |
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| Supplement Number | S007 |
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| Date Received | 07/07/1999 |
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| Decision Date | 08/25/1999 |
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| Reclassified Date | 05/18/2026 |
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| Product Code |
LPQ |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for a name change from SAFHS 2000(R) to Exogen 2000(R). The device is indicated for the acceleration of the time to a healed fracture for fresh*, closed, posteriorly displaced distal radius (Colles') fractures, and fresh*, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. *All fractures in both clinical studies were treated with SAFHS(R) therapy within seven days for fracture. |
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