Eversense Continuous Glucose Monitoring System

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Premarket Approval P160048 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

Approval for modification to the approved post-approval study protocol to include nurse practitioners and physicians assistants, in addition to physicians, as practitioners who will perform sensor insertions and removals.

DeviceEversense Continuous Glucose Monitoring System
Classification NameContinuous Glucose Monitor, Implanted, Adjunctive Use
Generic NameContinuous Glucose Monitor, Implanted, Adjunctive Use
ApplicantSENSEONICS, INCORPORATED
Date Received2018-11-28
Decision Date2019-01-15
PMAP160048
SupplementS007
Product CodeQCD
Advisory CommitteeClinical Chemistry
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SENSEONICS, INCORPORATED 20451 Seneca Meadows Parkway germantown, MD 20876-7005

Supplemental Filings

Supplement NumberDateSupplement Type
P160048Original Filing
S017 2020-11-12 30-day Notice
S016
S015
S014 2019-08-27 Normal 180 Day Track No User Fee
S013 2019-07-31 30-day Notice
S012
S011 2019-06-27 Normal 180 Day Track
S010 2019-06-24 30-day Notice
S009 2019-05-28 30-day Notice
S008 2018-12-11 Real-time Process
S007 2018-11-28 Normal 180 Day Track No User Fee
S006
S005 2018-09-11 Real-time Process
S004 2018-09-07 Real-time Process
S003 2018-08-27 Normal 180 Day Track No User Fee
S002 2018-08-07 Normal 180 Day Track
S001 2018-07-20 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
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00817491020819 P160048 000
00817491020826 P160048 000
00817491021328 P160048 000
00817491021304 P160048 000
00817491021311 P160048 000
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00817491022370 P160048 006
00817491022523 P160048 006
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00817491021342 P160048 016
00817491023063 P160048 016
00817491023520 P160048 016
00817491023537 P160048 016
00817491023841 P160048 016

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