PMA P900009S036
- Device
- EXOGEN ULTRASOUND BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S036
- Product code
- LPQ
- Decision date
- 2014-05-07
- 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 A MANUFACTURING SITE IN CORDOVA, TENNESSEE.
Current openFDA PMA Record#
- Device
- EXOGEN ULTRASOUND BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S036
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2014-05-07
- Decision code
- APPR
- Date received
- 2013-08-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE IN CORDOVA, TENNESSEE.