PMA P040025
- Device
- OLYMPIC COOL-CAP SYSTEM
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S014
- Product code
- MXM
- Decision date
- 2013-12-23
- Generic name
- Cap, cooling (infants)
- Approval order statement
- APPROVAL FOR A POST-APPROVAL STUDY (REGISTRY) LABELING UPDATE FOR THE OLYMPIC COOL-CAP SYSTEM.
Current openFDA PMA Record#
- Device
- OLYMPIC COOL-CAP SYSTEM
- Applicant
- Natus Medical Incorporated
- PMA number
- P040025
- Supplement
- S014
- Product code
- MXM
- Generic name
- Cap, cooling (infants)
- Decision date
- 2013-12-23
- Decision code
- APPR
- Date received
- 2013-06-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A POST-APPROVAL STUDY (REGISTRY) LABELING UPDATE FOR THE OLYMPIC COOL-CAP SYSTEM.