OXIFIRST(TM) FETAL SENSOR FS14-SERIES

Oximeter, Fetal Pulse

FDA Premarket Approval P990053 S002

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 an alternate manufacturing facility located at tyco healthcare group, tijuana, mexico.

DeviceOXIFIRST(TM) FETAL SENSOR FS14-SERIES
Classification NameOximeter, Fetal Pulse
Generic NameOximeter, Fetal Pulse
ApplicantCovidien, LLC
Date Received2001-06-05
Decision Date2001-12-19
PMAP990053
SupplementS002
Product CodeMMA
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonExpress Gmp Supplement
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.