PMA P900009S027
- Device
- EXOGEN 4000+BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S027
- Product code
- LPQ
- Decision date
- 2007-08-16
- 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 CHANGES IN INTERNAL DEVICE CIRCUITRY AS MITIGATION AGAINST KNOWN DEVICE FAILURE MECHANISMS WHICH DO NOT IMPACT UPON ULTRASOUND OUTPUT OR SIGNAL PARAMETERS.
Current openFDA PMA Record#
- Device
- EXOGEN 4000+BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S027
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2007-08-16
- Decision code
- APPR
- Date received
- 2007-07-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES IN INTERNAL DEVICE CIRCUITRY AS MITIGATION AGAINST KNOWN DEVICE FAILURE MECHANISMS WHICH DO NOT IMPACT UPON ULTRASOUND OUTPUT OR SIGNAL PARAMETERS.