PMA P900009S009
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S009
- Product code
- LPQ
- Decision date
- 2000-06-22
- 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 MANUFACTURING FACILITY AT SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION, MEMPHIS, TENNESSEE 38116.
Current openFDA PMA Record#
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S009
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2000-06-22
- Decision code
- APPR
- Date received
- 2000-04-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR THE MANUFACTURING FACILITY AT SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION, MEMPHIS, TENNESSEE 38116.