PMA P900009S023
- Device
- EXOGEN 2000+ BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S023
- Product code
- LPQ
- Decision date
- 2006-06-30
- 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 THE INCORPORATION OF A DRI-SHIELD 2000 MOISTURE BARRIER BAG (ELECTROSTATIC DISCHARGE [ESD] BAG) AS PART OF THE DEVICE PACKAGING.
Current openFDA PMA Record#
- Device
- EXOGEN 2000+ BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S023
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2006-06-30
- Decision code
- APPR
- Date received
- 2006-05-15
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE INCORPORATION OF A DRI-SHIELD 2000 MOISTURE BARRIER BAG (ELECTROSTATIC DISCHARGE [ESD] BAG) AS PART OF THE DEVICE PACKAGING.