Approval for a post-approval study (registry) labeling update for the olympic cool-cap system.
Device | OLYMPIC COOL-CAP SYSTEM |
Generic Name | Cap, Cooling (infants) |
Applicant | Natus Medical Incorporated |
Date Received | 2013-06-26 |
Decision Date | 2013-12-23 |
PMA | P040025 |
Supplement | S014 |
Product Code | MXM |
Advisory Committee | Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Pas |
Expedited Review | No |
Combination Product | No |
Applicant Address | Natus Medical Incorporated 5900 First Avenue South seattle, WA 98108 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P040025 | | Original 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