DEXCOM SEVEN PLUS SYSTEM

FDA Premarket Approval P050012 S046

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 to add an additional sealer in the pouch sealing process used to seal the dexcom seven sensors into tyvek porous pouches.

DeviceDEXCOM SEVEN PLUS SYSTEM
Generic NameSensor, Glucose, Invasive
ApplicantDEXCOM, INC.
Date Received2012-03-16
Decision Date2012-12-14
PMAP050012
SupplementS046
Product CodeMDS 
Advisory CommitteeClinical Chemistry
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DEXCOM, INC. 5555 Oberlin Dr san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P050012Original Filing
S052 2013-12-06 Real-time Process
S051 2013-07-26 30-day Notice
S050 2012-09-25 135 Review Track For 30-day Notice
S049 2012-09-24 30-day Notice
S048 2012-07-05 30-day Notice
S047 2012-05-30 30-day Notice
S046 2012-03-16 135 Review Track For 30-day Notice
S045 2012-02-21 Normal 180 Day Track
S044 2012-01-03 Real-time Process
S043 2011-12-21 30-day Notice
S042 2011-10-17 135 Review Track For 30-day Notice
S041 2011-08-15 135 Review Track For 30-day Notice
S040
S039 2011-08-15 135 Review Track For 30-day Notice
S038 2011-07-14 30-day Notice
S037 2011-04-08 Real-time Process
S036 2011-01-31 30-day Notice
S035 2010-12-08 135 Review Track For 30-day Notice
S034 2010-11-12 30-day Notice
S033 2010-11-12 135 Review Track For 30-day Notice
S032 2010-08-04 30-day Notice
S031 2010-07-30 Real-time Process
S030 2010-07-30 Real-time Process
S029 2010-07-30 30-day Notice
S028 2010-07-28 30-day Notice
S027 2010-07-13 Real-time Process
S026
S025 2010-06-15 Special (immediate Track)
S024 2010-05-12 30-day Notice
S023
S022 2009-12-30 30-day Notice
S021 2009-11-05 30-day Notice
S020 2009-08-26 30-day Notice
S019 2009-08-20 30-day Notice
S018 2009-03-09 Real-time Process
S017 2008-09-23 Normal 180 Day Track
S016 2008-08-04 Normal 180 Day Track
S015 2008-06-19 30-day Notice
S014 2008-04-01 Real-time Process
S013 2007-12-13 30-day Notice
S012 2007-08-20 Normal 180 Day Track No User Fee
S011 2007-06-05 Normal 180 Day Track
S010 2007-04-16 Real-time Process
S009 2007-03-26 30-day Notice
S008 2007-03-01 30-day Notice
S007 2007-02-06 30-day Notice
S006 2007-01-03 30-day Notice
S005 2006-12-06 30-day Notice
S004 2006-09-07 30-day Notice
S003 2006-08-21 30-day Notice
S002 2006-07-28 Real-time Process
S001 2006-06-19 Panel Track

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