PMA P900009S010
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM/EXOGEN 3000 (TM)
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S010
- Product code
- LPQ
- Decision date
- 2000-05-10
- 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 change in the wording of the indication statement.
Current openFDA PMA Record#
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM/EXOGEN 3000 (TM)
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S010
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2000-05-10
- Decision code
- APPR
- Date received
- 2000-04-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change in the wording of the indication statement.