OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Premarket Approval P990053 S007

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 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.

DeviceOXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Classification NameOximeter, Fetal Pulse
Generic NameOximeter, Fetal Pulse
ApplicantCovidien, LLC
Date Received2002-04-05
Decision Date2002-04-18
PMAP990053
SupplementS007
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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