Paradigm REAL-Time Revel Insulin Pump

FDA premarket approval P150019/S029 · decided 2017-05-10

Approval details

PMA number

P150019

Supplement

S029

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Paradigm REAL-Time Revel Insulin Pump

Generic name

Sensor, glucose, invasive

Applicant

Medtronic Minimed

Date received

2017-04-10

Decision date

2017-05-10

Days to decision

30 days

Decision code

OK30

Product code

MDS

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

Transfer equipment used for leak testing seals of the Paradigm insulin infusion pumps and Next Generation insulin infusion pumps from Medtronic MiniMed to a sub-tier supplier, as well as transferring the task of performing such testing to the sub-tier supplier. The Paradigm insulin infusion pump is component of the Paradigm REAL-Time System, the Paradigm REAL-Time Revel System, and the MiniMed 530G System. The Next Generation insulin infusion pump is a component of the MiniMed 630G System and th

510(k) clearances by this applicant