PMA P160048S003

Device: Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S003
Product code: QCD
Decision date: 2019-02-01
Classification: Continuous Glucose Monitor, Implanted, Adjunctive Use
Generic name: Continuous glucose monitor, implanted, adjunctive use
Approval order statement: Approval to add final packaging, storage, and distribution activities for the Eversense Continuous Glucose Monitoring System at Woodfield Distribution, LLC, Boca Raton, FL.

Current openFDA PMA Record#

Device: Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S003
Product code: QCD
Generic name: Continuous glucose monitor, implanted, adjunctive use
Decision date: 2019-02-01
Decision code: APPR
Date received: 2018-08-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to add final packaging, storage, and distribution activities for the Eversense Continuous Glucose Monitoring System at Woodfield Distribution, LLC, Boca Raton, FL.