FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Cap, Cooling (Infants)
PMA: P040025
·
Supplement: S005
·
Decision Sep 21, 2007
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Cap, Cooling (Infants)
- Trade Name
- COOL CAP SYSTEM
- PMA Number
- P040025
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- MXM
- Generic Name
- Cap, cooling (infants)
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 21, 2007
- Date Received
- August 24, 2007
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
REPLACING A MECHANICAL TEST GAUGE WITH AN ELECTRONIC GAUGE AND THE RELEASE OF AN ACCEPTANCE TEST PROCEDURE FOR THE PERIODIC VERIFICATION OF ALL TEST FIXTURES.
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 |