OLYMPIC COOL-CAP SYSTEM
FDA premarket approval P040025/S014 · decided 2013-12-23
Approval details
- PMA number
- P040025
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- OLYMPIC COOL-CAP SYSTEM
- Generic name
- Cap, cooling (infants)
- Applicant
- Natus Medical Incorporated
- Date received
- 2013-06-26
- Decision date
- 2013-12-23
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MXM
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Seattle, WA
- Statement
- APPROVAL FOR A POST-APPROVAL STUDY (REGISTRY) LABELING UPDATE FOR THE OLYMPIC COOL-CAP SYSTEM.
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