SONIC ACCELERATED FRACTURE HEALING SYSTEM
FDA premarket approval P900009/S007 · decided 1999-08-25
Approval details
- PMA number
- P900009
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 1999-07-07
- Decision date
- 1999-08-25
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- 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
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