PMA P900009S021
- Device
- EXOGEN BONE HEALING SYSTEM 2000 ,3000
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S021
- Product code
- LPQ
- Decision date
- 2008-12-19
- 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 LABELING MODIFICATIONS AIMED TO SIMPLIFY THE DEVICE LABELING.
Current openFDA PMA Record#
- Device
- EXOGEN BONE HEALING SYSTEM 2000 ,3000
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S021
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2008-12-19
- Decision code
- APPR
- Date received
- 2005-08-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING MODIFICATIONS AIMED TO SIMPLIFY THE DEVICE LABELING.