MINIMED 530G SYSTEM

FDA premarket approval P120010/S083 · decided 2016-03-23

Approval details

PMA number

P120010

Supplement

S083

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

MINIMED 530G SYSTEM

Generic name

Automated insulin dosing , threshold suspend

Applicant

Medtronic, Inc.

Date received

2016-02-23

Decision date

2016-03-23

Days to decision

29 days

Decision code

OK30

Product code

OZO

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

Manufacturing facility move by Medtronic’s Enlite sensor substrate supplier. The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor. The sensor substrate supplier, Metrigraphics, LLC, currently manufactures the Enlite sensor substrate in Wilmington, Massachusetts and will start manufacturing at the new facility in Lowell, Massachusetts. The firm states that the current sensor substrate manufacturing facility will close at the end of

510(k) clearances by this applicant