PMA P120005S090

Device: DEXCOM G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S090
Product code: MDS
Decision date: 2023-01-12
Generic name: Sensor, glucose, invasive
Approval order statement: Approval to modify the prior inclusion criterion to the following: Clinical diagnosis of Type 1 or Type 2 diabetes with at least one (1) week of insulin initiation at time of study entry.

Current openFDA PMA Record#

Device: DEXCOM G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S090
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2023-01-12
Decision code: APPR
Date received: 2022-10-14
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval to modify the prior inclusion criterion to the following: Clinical diagnosis of Type 1 or Type 2 diabetes with at least one (1) week of insulin initiation at time of study entry.