OLYMPIC COOL-CAP SYSTEM

FDA Premarket Approval P040025 S007

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

Approval for design changes associated with software upgrade from cool-cap 1. 0 to cool-cap 1. 1, as well as associated labeling changes.

DeviceOLYMPIC COOL-CAP SYSTEM
Generic NameCap, Cooling (infants)
ApplicantNatus Medical Incorporated
Date Received2008-07-16
Decision Date2009-04-22
PMAP040025
SupplementS007
Product CodeMXM 
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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