PMA P900009S008
- Device
- EXOGEN 3000
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S008
- Product code
- LPQ
- Decision date
- 2000-04-14
- 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 various design and manufacturing changes which do not affect the output of the device. The device, as modified, will be marketed under the trade name Exogen 3000.
Current openFDA PMA Record#
- Device
- EXOGEN 3000
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S008
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2000-04-14
- Decision code
- APPR
- Date received
- 1999-10-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for various design and manufacturing changes which do not affect the output of the device. The device, as modified, will be marketed under the trade name Exogen 3000.