DEXCOM SEVEN & SEVEN PLUS SYSTEM

FDA Premarket Approval P050012 S033

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 proposed change to eliminate redundant post-winding and post-second-parylene visual inspection for the sensor component of the seven and seven plus continuous glucose monitoring system.

DeviceDEXCOM SEVEN & SEVEN PLUS SYSTEM
Generic NameSensor, Glucose, Invasive
ApplicantDEXCOM, INC.
Date Received2010-11-12
Decision Date2011-05-19
PMAP050012
SupplementS033
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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