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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 NumberS012
Date Received03/04/2005
Decision Date06/24/2005
Withdrawal Date 06/02/2017
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 ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATIVE VENDOR OF RAW CABLE AND FETAL SENSOR CABLE WITHIN THE OXIMETRY SENSOR.
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