MiniMed 530G Insulin Pump

FDA premarket approval P120010/S093 · decided 2016-08-25

Approval details

PMA number

P120010

Supplement

S093

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

MiniMed 530G Insulin Pump

Generic name

Automated insulin dosing , threshold suspend

Applicant

Medtronic, Inc.

Date received

2016-07-26

Decision date

2016-08-25

Days to decision

30 days

Decision code

OK30

Product code

OZO

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

Add a new testing station to conduct a Manual Bolus Time Test (BTT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps. These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico.

510(k) clearances by this applicant