COOL CAP SYSTEM

FDA Premarket Approval P040025 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceCOOL CAP SYSTEM
Generic NameCap, Cooling (infants)
ApplicantNatus Medical Incorporated
Date Received2007-08-24
Decision Date2007-09-21
PMAP040025
SupplementS005
Product CodeMXM 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Natus Medical Incorporated 5900 First Avenue South seattle, WA 98108

Supplemental Filings

Supplement NumberDateSupplement Type
P040025Original Filing
S014 2013-06-26 Normal 180 Day Track No User Fee
S013 2013-05-28 Normal 180 Day Track
S012 2012-01-26 Real-time Process
S011 2010-09-29 Real-time Process
S010 2010-05-03 Real-time Process
S009 2009-07-21 Real-time Process
S008 2008-10-27 Real-time Process
S007 2008-07-16 Normal 180 Day Track
S006 2007-10-24 Real-time Process
S005 2007-08-24 30-day Notice
S004
S003
S002
S001

NIH GUDID Devices

Device IDPMASupp
00382830016308 P040025 000
00382830009584 P040025 000
00382830009577 P040025 000
00382830009560 P040025 000
00382830004169 P040025 000
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