PMA P900009S014
- Device
- EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S014
- Product code
- LPQ
- Decision date
- 2002-11-18
- 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 LABELING CHANGES TO THE PHYSICIAN'S INSTRUCTIONS FOR USE.
Current openFDA PMA Record#
- Device
- EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S014
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2002-11-18
- Decision code
- APPR
- Date received
- 2001-12-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE PHYSICIAN'S INSTRUCTIONS FOR USE.