PMA P900009S007
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S007
- Product code
- LPQ
- Decision date
- 1999-08-25
- Classification
- Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- 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.
Current openFDA PMA Record#
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S007
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 1999-08-25
- Decision code
- APPR
- Date received
- 1999-07-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.