PMA P040025S007
- Device
- OLYMPIC COOL-CAP SYSTEM
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S007
- Product code
- MXM
- Decision date
- 2009-04-22
- Generic name
- Cap, cooling (infants)
- Approval order statement
- APPROVAL FOR DESIGN CHANGES ASSOCIATED WITH SOFTWARE UPGRADE FROM COOL-CAP 1.0 TO COOL-CAP 1.1, AS WELL AS ASSOCIATED LABELING CHANGES.
Current openFDA PMA Record#
- Device
- OLYMPIC COOL-CAP SYSTEM
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S007
- Product code
- MXM
- Generic name
- Cap, cooling (infants)
- Decision date
- 2009-04-22
- Decision code
- APPR
- Date received
- 2008-07-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGES ASSOCIATED WITH SOFTWARE UPGRADE FROM COOL-CAP 1.0 TO COOL-CAP 1.1, AS WELL AS ASSOCIATED LABELING CHANGES.