OLYMPIC COOL-CAP SYSTEM
FDA premarket approval P040025/S008 · decided 2008-12-24
Approval details
- PMA number
- P040025
- Supplement
- S008
- 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
- 2008-10-27
- Decision date
- 2008-12-24
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MXM
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Seattle, WA
- Statement
- APPROVAL FOR MINOR HARDWARE AND SOFTWARE DESIGN CHANGES TO THE OLYMPIC COOL-CAP SYSTEM RELATED TO A CPU (PROCESSOR) THAT HAS GONE END-OF-LIFE.
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