PMA P900009S029
- Device
- EXOGEN 4000+BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S029
- Product code
- LPQ
- Decision date
- 2008-12-18
- 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 TO CHANGE THE LOCATION OF THE DISTRIBUTION AND STORAGE FACILITIES TO A FACILITY IN MEMPHIS, TENNESSEE.
Current openFDA PMA Record#
- Device
- EXOGEN 4000+BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S029
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2008-12-18
- Decision code
- OK30
- Date received
- 2008-11-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CHANGE THE LOCATION OF THE DISTRIBUTION AND STORAGE FACILITIES TO A FACILITY IN MEMPHIS, TENNESSEE.