SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000
FDA premarket approval P900009/S009 · decided 2000-06-22
Approval details
- PMA number
- P900009
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2000-04-03
- Decision date
- 2000-06-22
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR THE MANUFACTURING FACILITY AT SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION, MEMPHIS, TENNESSEE 38116.
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