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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
NELLCOR PURITAN BENNETT, INC.
4280 hacienda dr.
pleasanton, CA 94588-2719
PMA NumberP990053
Supplement NumberS007
Date Received04/05/2002
Decision Date04/18/2002
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE MANUFACTURING SITE FOR THE FETAL SENSOR EMITTER, A COMPONENT OF THE OXIFIRST FETAL SENSOR. THE SENSOR EMITTER WILL BE MANUFACTURED AT THE TYCO FACILITY IN INSURGENTES, TIJUANA, MEXICO, WHERE THE FETAL SENSORS ARE MANUFACTURED.
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