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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
Generic NameOximeter, fetal pulse
ApplicantCovidien, LLC
6135 Gunbarrel Avenue
Boulder, CO 80301
PMA NumberP990053
Supplement NumberS010
Date Received10/17/2002
Decision Date11/15/2002
Withdrawal Date 06/02/2017
Product Code MMA 
Advisory Committee Obstetrics/Gynecology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE LABELING.
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