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Sensor-Enabled Pump System-Continuous Glucose Monitoring System

FDA premarket approval P150019/S016 · decided 2016-12-08

Approval details

PMA number
P150019
Supplement
S016
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Sensor-Enabled Pump System-Continuous Glucose Monitoring System
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2016-06-15
Decision date
2016-12-08
Days to decision
176 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Approval for adding a Cell Operating System (COS) for partial manual assembly of Enlite Sensors at Medtronic Puerto Rico Operations Company (MPROC) facility. The implementation of a COS includes adding new equipment and relocating existing equipment within the existing Enlite sensor manual assembly line. The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.

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