PMA P900009S038
- Device
- EXOGEN ULTRASOUND BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S038
- Product code
- LPQ
- Decision date
- 2014-12-08
- 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
- ADDITION OF A NEW SERVICING PROCESS.
Current openFDA PMA Record#
- Device
- EXOGEN ULTRASOUND BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S038
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2014-12-08
- Decision code
- OK30
- Date received
- 2014-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW SERVICING PROCESS.