PMA P040025S008
- Device
- OLYMPIC COOL-CAP SYSTEM
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S008
- Product code
- MXM
- Decision date
- 2008-12-24
- Generic name
- Cap, cooling (infants)
- Approval order 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.
Current openFDA PMA Record#
- Device
- OLYMPIC COOL-CAP SYSTEM
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S008
- Product code
- MXM
- Generic name
- Cap, cooling (infants)
- Decision date
- 2008-12-24
- Decision code
- APPR
- Date received
- 2008-10-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.