OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Premarket Approval P990053 S003

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.

Pre-market Approval Supplement Details

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.

DeviceOXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Classification NameOximeter, Fetal Pulse
Generic NameOximeter, Fetal Pulse
ApplicantCovidien, LLC
Date Received2001-10-12
Decision Date2001-11-09
PMAP990053
SupplementS003
Product CodeMMA
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Covidien, LLC 6135 Gunbarrel Avenue boulder, CO 80301

Supplemental Filings

Supplement NumberDateSupplement Type
P990053Original Filing
S012 2005-03-04 135 Review Track For 30-day Notice
S011 2004-11-22 135 Review Track For 30-day Notice
S010 2002-10-17 Special (immediate Track)
S009 2002-04-17 Normal 180 Day Track
S008 2002-04-16 Normal 180 Day Track
S007 2002-04-05 30-day Notice
S006 2002-03-26 Normal 180 Day Track
S005 2001-12-31 Normal 180 Day Track
S004
S003 2001-10-12 30-day Notice
S002 2001-06-05 Normal 180 Day Track
S001 2001-04-09 Normal 180 Day Track

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