PMA P900009S017
- Device
- EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S017
- Product code
- LPQ
- Decision date
- 2003-04-22
- 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 ADDITION OF A NEW CIRCUIT BOARD INSPECTION STEP FOR THE EXOGEN 2000+ DEVICE.
Current openFDA PMA Record#
- Device
- EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S017
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2003-04-22
- Decision code
- APPR
- Date received
- 2003-03-03
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF A NEW CIRCUIT BOARD INSPECTION STEP FOR THE EXOGEN 2000+ DEVICE.