PMA P900009S011
- Device
- EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S011
- Product code
- LPQ
- Decision date
- 2000-09-08
- 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 CONDITIONS OF APPROVAL TO TERMINATE THE REQUIREMENT FOR A PRESCRIPTION REGISTRY.
Current openFDA PMA Record#
- Device
- EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S011
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2000-09-08
- Decision code
- APPR
- Date received
- 2000-07-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR A CHANGE IN THE CONDITIONS OF APPROVAL TO TERMINATE THE REQUIREMENT FOR A PRESCRIPTION REGISTRY.