• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOLYMPIC COOL-CAP SYSTEM
Classification Namecap,cooling (infants)
Generic Namecooling cap (infants)
ApplicantOLYMPIC MEDICAL CORP.
PMA NumberP040025
Supplement NumberS010
Date Received05/03/2010
Decision Date06/28/2010
Product Code
MXM[ Registered Establishments with MXM ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the olympic cool-cap system software version 2. 0.
-
-