PMA P900009S031
- Device
- EXOGEN BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S031
- Product code
- LPQ
- Decision date
- 2009-10-02
- 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 LOCATED IN MEMPHIS, TENNESSEE.
Current openFDA PMA Record#
- Device
- EXOGEN BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S031
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2009-10-02
- Decision code
- APPR
- Date received
- 2009-06-09
- 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 LOCATED IN MEMPHIS, TENNESSEE.