PMA P900009S025
- Device
- EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S025
- Product code
- LPQ
- Decision date
- 2007-06-11
- 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 AN ADDITIONAL SUPPLIER OF THE EXTERNAL PLASTIC HOUSING FOR THE MAIN OPERATING UNIT. THIS INCLUDES THE TOP HOUSING, THE BOTTOM HOUSING, THE PUSH BUTTON AND THE LENS.
Current openFDA PMA Record#
- Device
- EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S025
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2007-06-11
- Decision code
- APPR
- Date received
- 2007-02-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER OF THE EXTERNAL PLASTIC HOUSING FOR THE MAIN OPERATING UNIT. THIS INCLUDES THE TOP HOUSING, THE BOTTOM HOUSING, THE PUSH BUTTON AND THE LENS.