EXOGEN 2000+
FDA premarket approval P900009/S019 · decided 2004-05-07
Approval details
- PMA number
- P900009
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXOGEN 2000+
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2004-03-05
- Decision date
- 2004-05-07
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR THE ADDITION OF 2 DIODES IN SERIES WITH THE POSITIVE LEAD OF THE 5-CELL BATTERY PACK ON THE EXOGEN 2000+ LOW INTENSITY ULTRASOUND FRACTURE HEALING SYSTEM.
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