Guardian Sensor (3) System

FDA premarket approval P160007/S005 · decided 2018-06-26

Approval details

PMA number

P160007

Supplement

S005

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Guardian Sensor (3) System

Generic name

Sensor, glucose, invasive

Applicant

Medtronic Minimed

Date received

2018-05-31

Decision date

2018-06-26

Days to decision

26 days

Decision code

OK30

Product code

MDS

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

Manufacturing changes for the Guardian Sensor (3): 1) adding a new ISO Class 8 Cleanroom for the manufacturing of Enlite Sensors and Guardian Sensors (3); 2) adding a new press, two new molds and a new quality control measurement system at the contract manufacturer; 3) adding an alternate injection molding machine and mold to produce the needle hub body component; 4) adding an alternative mask aligner; 5) adding a new electroplating machine; 6) adding a new sterilization site for the Enlite Sens

510(k) clearances by this applicant