OLYMPIC COOL CAP
FDA premarket approval P040025/S013 · decided 2013-08-29
Approval details
- PMA number
- P040025
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OLYMPIC COOL CAP
- Generic name
- Cap, cooling (infants)
- Applicant
- Natus Medical Incorporated
- Date received
- 2013-05-28
- Decision date
- 2013-08-29
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- MXM
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Seattle, WA
- Statement
- APPROVAL FOR A SOFTWARE PATCH THAT ALLOWS THE WATCHDOG TIMER TO REBOOT THE DEVICE AND INITIATE A POWER FAILURE RECOVERY ALARM IN THE EVENT OF A SCREEN FREEZE CONDITION.
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