FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Cap, Cooling (Infants)
PMA: P040025
·
Decision Dec 20, 2006
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Cap, Cooling (Infants)
- Trade Name
- OLYMPIC COOL-CAP
- PMA Number
- P040025
- Device Class
- FDA Class 3
- Product Code
- MXM
- Generic Name
- Cap, cooling (infants)
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- December 20, 2006
- Date Received
- May 28, 2004
- Expedited Review
- Y
- Docket Number
- 06M-0530
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MXM | Cap, Cooling (Infants) | FDA class 3 | Unknown |