PMA P160048S012

Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Senseonics, Incorporated
Product code: QHJ
Decision date: 2019-11-25
Generic name: Sensor, glucose, implanted, non-adjunctive use
Approval order statement: Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P160048/S006

Current openFDA PMA Record#

Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S012
Product code: QHJ
Generic name: Sensor, glucose, implanted, non-adjunctive use
Decision date: 2019-11-25
Decision code: APPR
Date received: 2019-07-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P160048/S006