PMA P040025S012

Device
OLYMPIC COOL-CAP SYSTEM
Applicant
Natus Medical Incorporated
PMA number
P040025
Supplement
S012
Product code
MXM
Decision date
2012-03-27
Generic name
Cap, cooling (infants)
Approval order statement
APPROVAL FOR A REDESIGNED PRINTED CIRCUIT BOARD (THE SYSCAM PCB, PREVIOUSLY PN 401339 AND NOW PN 002819), FOR THE DEVICE.

Current openFDA PMA Record#

Device
OLYMPIC COOL-CAP SYSTEM
Applicant
Natus Medical Incorporated
PMA number
P040025
Supplement
S012
Product code
MXM
Generic name
Cap, cooling (infants)
Decision date
2012-03-27
Decision code
APPR
Date received
2012-01-26
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A REDESIGNED PRINTED CIRCUIT BOARD (THE SYSCAM PCB, PREVIOUSLY PN 401339 AND NOW PN 002819), FOR THE DEVICE.