OLYMPIC COOL-CAP SYSTEM
FDA premarket approval P040025/S006 · decided 2008-02-05
Approval details
- PMA number
- P040025
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OLYMPIC COOL-CAP SYSTEM
- Generic name
- Cap, cooling (infants)
- Applicant
- Natus Medical Incorporated
- Date received
- 2007-10-24
- Decision date
- 2008-02-05
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- MXM
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Seattle, WA
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE PUMP MOTOR DRIVE AND CHANGES TO THE CONTROL MODULE AND TEMPERATURE SENSOR MODULE TO RELIABLY MEET ELECTRICAL FAST TRANSIENT (EFT) TESTING.
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