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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceOXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Classification Nameoximeter, fetal pulse
Generic Nameoximeter, fetal pulse
Applicant
Covidien, LLC
6135 gunbarrel avenue
boulder, CO 80301
PMA NumberP990053
Supplement NumberS011
Date Received11/22/2004
Decision Date02/25/2005
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE QUALIFICATION OF AN ADDITIONAL SUPPLIER FOR THE TWO LIGHT EMITTING DIODES WITHIN THE OXIMETRY SENSOR.
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