PMA P900009S016
- Device
- EXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S016
- Product code
- LPQ
- Decision date
- 2003-02-21
- 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 TO THE EXOGEN 3000* LABELING IN ORDER THAT IT MORE CLOSELY RESEMBLE THE APPROVED LABELING FOR THE EXOGEN 2000+*.
Current openFDA PMA Record#
- Device
- EXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S016
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2003-02-21
- Decision code
- APPR
- Date received
- 2002-12-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE EXOGEN 3000* LABELING IN ORDER THAT IT MORE CLOSELY RESEMBLE THE APPROVED LABELING FOR THE EXOGEN 2000+*.