EXOGEN 4000+BONE HEALING SYSTEM
FDA premarket approval P900009/S027 · decided 2007-08-16
Approval details
- PMA number
- P900009
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXOGEN 4000+BONE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2007-07-10
- Decision date
- 2007-08-16
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR CHANGES IN INTERNAL DEVICE CIRCUITRY AS MITIGATION AGAINST KNOWN DEVICE FAILURE MECHANISMS WHICH DO NOT IMPACT UPON ULTRASOUND OUTPUT OR SIGNAL PARAMETERS.
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