PMA P160048S014

Device: Eversense Continuous Glucose Monitoring System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S014
Product code: QHJ
Decision date: 2019-10-29
Classification: Continuous Glucose Monitor, Implanted, Adjunctive Use
Generic name: Sensor, glucose, implanted, non-adjunctive use
Approval order statement: Approval for a manufacturing site located at Steris Isomedix Services, 3459 South Clinton Ave., South Plainfield, NJ 07080 for use as a sterilization site for the sensor insertion tools of the Eversense Continuous Glucose Monitoring System.

Current openFDA PMA Record#

Device: Eversense Continuous Glucose Monitoring System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S014
Product code: QHJ
Generic name: Sensor, glucose, implanted, non-adjunctive use
Decision date: 2019-10-29
Decision code: APPR
Date received: 2019-08-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Steris Isomedix Services, 3459 South Clinton Ave., South Plainfield, NJ 07080 for use as a sterilization site for the sensor insertion tools of the Eversense Continuous Glucose Monitoring System.