OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Premarket Approval P990053 S009

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

Approval for a new manufacturing facility located at nellcor puritan bennett, inc. , minneapolis, minnesota. This facility will perform manufacturing of the fsp02-pm fetal patient modules.

DeviceOXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
Classification NameOximeter, Fetal Pulse
Generic NameOximeter, Fetal Pulse
ApplicantCovidien, LLC
Date Received2002-04-17
Decision Date2002-11-25
PMAP990053
SupplementS009
Product CodeMMA
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation 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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