OLYMPIC COOL-CAP
FDA premarket approval P040025 · decided 2006-12-20
Approval details
- PMA number
- P040025
- Trade name
- OLYMPIC COOL-CAP
- Generic name
- Cap, cooling (infants)
- Applicant
- Natus Medical Incorporated
- Date received
- 2004-05-28
- Decision date
- 2006-12-20
- Days to decision
- 936 days
- Decision code
- APWD
- Product code
- MXM
- Advisory committee
- Neurology
- Expedited review
- Yes
- Location
- Seattle, WA
- Statement
- APPROVAL FOR THE OLYMPIC COOL-CAP. THE OLYMPIC COOL-CAP IS INDICATED FOR USE IN FULL-TERM INFANTS WITH CLINICAL EVIDENCE OF MODERATE TO SEVERE HYPOXIC-ISCHEMIC ENCEPHALOPATHY (HIE). COOL-CAP PROVIDES SELECTIVE HEAD COOLING WITH MILD SYSTEMIC HYPOTHERMIA TO PREVENT OR REDUCE THE SEVERITY OF NEUROLOGIC INJURY ASSOCIATED WITH HIE.
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