EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
FDA premarket approval P900009/S015 · decided 2002-03-29
Approval details
- PMA number
- P900009
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2001-12-13
- Decision date
- 2002-03-29
- Days to decision
- 106 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT SMITH & NEPHEW, INC., MEMPHIS, TENNESSEE.
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| StimTrial Neuromodulation System (K243782) | Bioventus, LLC | 2025-07-16 |
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| MCS Bone Graft (K162860) | Bioventus, LLC | 2017-02-13 |