PMA P900009S019
- Device
- EXOGEN 2000+
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S019
- Product code
- LPQ
- Decision date
- 2004-05-07
- 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 THE ADDITION OF 2 DIODES IN SERIES WITH THE POSITIVE LEAD OF THE 5-CELL BATTERY PACK ON THE EXOGEN 2000+ LOW INTENSITY ULTRASOUND FRACTURE HEALING SYSTEM.
Current openFDA PMA Record#
- Device
- EXOGEN 2000+
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S019
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2004-05-07
- Decision code
- APPR
- Date received
- 2004-03-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF 2 DIODES IN SERIES WITH THE POSITIVE LEAD OF THE 5-CELL BATTERY PACK ON THE EXOGEN 2000+ LOW INTENSITY ULTRASOUND FRACTURE HEALING SYSTEM.