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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
Generic NameOximeter, fetal pulse
ApplicantCovidien, LLC
6135 Gunbarrel Ave.
Boulder, CO 80301
PMA NumberP990053
Supplement NumberS002
Date Received06/05/2001
Decision Date12/19/2001
Withdrawal Date06/02/2017
Product Code MMA 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT TYCO HEALTHCARE GROUP, TIJUANA, MEXICO.
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