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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 NumberS006
Date Received03/26/2002
Decision Date01/07/2003
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE N-400 FETAL PULSE OXIMETER. THE MANUFACTURING SITE IS LOCATED AT NELLCOR PURITAN BENNETT IRELAND, GALWAY, IRELAND.
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