PMA P160048S007

Device: Eversense Continuous Glucose Monitoring System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S007
Product code: QCD
Decision date: 2019-01-15
Classification: Continuous Glucose Monitor, Implanted, Adjunctive Use
Generic name: Continuous glucose monitor, implanted, adjunctive use
Approval order statement: 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.

Current openFDA PMA Record#

Device: Eversense Continuous Glucose Monitoring System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S007
Product code: QCD
Generic name: Continuous glucose monitor, implanted, adjunctive use
Decision date: 2019-01-15
Decision code: APPR
Date received: 2018-11-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: 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.