This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the olympic cool-cap. The olympic cool-cap is indicated for use in full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (hie). Cool-cap provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with hie.
| Device | OLYMPIC COOL-CAP |
| Generic Name | Cap, Cooling (infants) |
| Applicant | Natus Medical Incorporated |
| Date Received | 2004-05-28 |
| Decision Date | 2006-12-20 |
| Notice Date | 2006-12-26 |
| PMA | P040025 |
| Supplement | S |
| Product Code | MXM |
| Docket Number | 06M-0530 |
| Advisory Committee | Neurology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Natus Medical Incorporated 5900 First Avenue South seattle, WA 98108 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00382830016308 | P040025 | 000 |
| 00382830009584 | P040025 | 000 |
| 00382830009577 | P040025 | 000 |
| 00382830009560 | P040025 | 000 |
| 00382830004169 | P040025 | 000 |