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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 NumberS003
Date Received10/12/2001
Decision Date11/09/2001
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 STERILIZATION PROCESS BY ELIMINATING THE POST STERILIZATION VISUAL INSPECTION FOR THE OXYFIRST FETAL SENSOR FS14-SERIES. ALSO, A CHANGE IN THE SITE OF FINAL PRODUCT DISTRIBUTION FROM THE PRESENT FACILITY IN CARLSBAD, CALIFORNIA TO A TYCO DISTRIBUTION FACILITY IN ATLANTA, GEORGIA.
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