PMA P900009S015
- Device
- EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S015
- Product code
- LPQ
- Decision date
- 2002-03-29
- 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 LOCATED AT SMITH & NEPHEW, INC., MEMPHIS, TENNESSEE.
Current openFDA PMA Record#
- Device
- EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S015
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2002-03-29
- Decision code
- APPR
- Date received
- 2001-12-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT SMITH & NEPHEW, INC., MEMPHIS, TENNESSEE.