PMA P900009S001
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S001
- Product code
- LPQ
- Decision date
- 1995-07-07
- 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 SUPPLEMENTARY REFERENCES FOR PHYSICIAN INSTALLATION AND PATIENT USE OF THE SAFHS MODEL 2A DEVICE
Current openFDA PMA Record#
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S001
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 1995-07-07
- Decision code
- APPR
- Date received
- 1995-02-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR SUPPLEMENTARY REFERENCES FOR PHYSICIAN INSTALLATION AND PATIENT USE OF THE SAFHS MODEL 2A DEVICE