OLYMPIC COOL-CAP SYSTEM
FDA premarket approval P040025/S007 · decided 2009-04-22
Approval details
- PMA number
- P040025
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OLYMPIC COOL-CAP SYSTEM
- Generic name
- Cap, cooling (infants)
- Applicant
- Natus Medical Incorporated
- Date received
- 2008-07-16
- Decision date
- 2009-04-22
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- MXM
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Seattle, WA
- Statement
- APPROVAL FOR DESIGN CHANGES ASSOCIATED WITH SOFTWARE UPGRADE FROM COOL-CAP 1.0 TO COOL-CAP 1.1, AS WELL AS ASSOCIATED LABELING CHANGES.
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