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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(TM) FETAL SENSOR FS14-SERIES
Classification Nameoximeter, fetal pulse
Generic Nameoximeter, fetal pulse
Applicant
NELLCOR PURITAN BENNETT, INC.
4280 hacienda dr.
pleasanton, CA 94588-2719
PMA NumberP990053
Supplement NumberS002
Date Received06/05/2001
Decision Date12/19/2001
Product Code
MMA
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT TYCO HEALTHCARE GROUP, TIJUANA, MEXICO.
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