PMA P900009S035
- Device
- EXOGEN ULTRASOUND BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S035
- Product code
- LPQ
- Decision date
- 2014-05-29
- 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 NEW BIOVENTUS MANUFACTURING FACILITY IN CORDOVA, TENNESSEE, MANUFACTURING PROCESS CHANGES, A RECHARGEABLE BATTERY AND CHARGER, REDESIGN OF THE MAIN OPERATING UNIT, CHANGES TO THE INSTRUCTIONS FOR USE, AND MODIFIED PACKAGING.
Current openFDA PMA Record#
- Device
- EXOGEN ULTRASOUND BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S035
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2014-05-29
- Decision code
- APPR
- Date received
- 2013-07-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW BIOVENTUS MANUFACTURING FACILITY IN CORDOVA, TENNESSEE, MANUFACTURING PROCESS CHANGES, A RECHARGEABLE BATTERY AND CHARGER, REDESIGN OF THE MAIN OPERATING UNIT, CHANGES TO THE INSTRUCTIONS FOR USE, AND MODIFIED PACKAGING.