EXOGEN 2000+ AND EXOGEN 3000
FDA premarket approval P900009/S018 · decided 2004-03-12
Approval details
- PMA number
- P900009
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXOGEN 2000+ AND EXOGEN 3000
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2004-01-29
- Decision date
- 2004-03-12
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR TWO DESIGN AND COMPONENT CHANGES: 1) CHANGES TO EXOGEN 2000+ PRINTED CIRCUIT BOARD TO IMPLEMENT CORRECTIVE ACTION FOR FIELD FAILURE AND RETURNS. THIS CORRECTIVE ACTION INVOLVES TWO DESIGN CHANGES: I) REPLACE 2 DIODES ON TE PRINTED CIRCUIT BOARD WITH LIGHT EMITTING DIODES. II) ADD A 1000 PF CAPACITOR TO REDUCE ELECTRICAL NOISE. 2) REPLACE BOTH EXOGEN 2000+ AND EXOGEN 3000 TRANSDUCER CABLES WITH A MORE COST EFFECTIVE MODEL.
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