PMA P900009S028
- Device
- EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S028
- 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
- CHANGE IN THE MANUFACTURE OF THE EXOGEN 4000+ DEVICE TO A CONTINUOUS FLOW MANUFACTURING MODEL AND A CHANGE IN THE SERIAL NUMBERING SCHEME OF THE DEVICE.
Current openFDA PMA Record#
- Device
- EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S028
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2007-08-16
- Decision code
- OK30
- Date received
- 2007-07-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE MANUFACTURE OF THE EXOGEN 4000+ DEVICE TO A CONTINUOUS FLOW MANUFACTURING MODEL AND A CHANGE IN THE SERIAL NUMBERING SCHEME OF THE DEVICE.