PMA P900009S020
- Device
- EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S020
- Product code
- LPQ
- Decision date
- 2005-05-19
- 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
- ADDITION OF A NEW CONTRACT VENDOR FOR THE SUPPLY OF COMPONENTS/ MATERIALS USED IN THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S020
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2005-05-19
- Decision code
- OK30
- Date received
- 2005-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW CONTRACT VENDOR FOR THE SUPPLY OF COMPONENTS/ MATERIALS USED IN THE MANUFACTURING PROCESS.