MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSORS ON PHILLIPS BASE MODELS MMT-7002, MMT-7003

FDA premarket approval P980022/S048 · decided 2009-04-09

Approval details

PMA number

P980022

Supplement

S048

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSORS ON PHILLIPS BASE MODELS MMT-7002, MMT-7003

Generic name

Sensor, glucose, invasive

Applicant

Medtronic Minimed

Date received

2009-02-27

Decision date

2009-04-09

Days to decision

41 days

Decision code

APPR

Product code

MDS

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

APPROVAL FOR DESIGN CHANGES TO THE MMT-7002 AND MMT-7003 GLUCOSE SENSORS MODELS AND A NEW SUPPLIER QUALIFICATION. THE DESIGN CHANGESINCLUDED AN INCREASE OF THE NEEDLE TUNNEL HEIGHT AND BASE FROM 0.034" TO 0.036" AND0.030" AND 0.031", RESPECTIVELY. THESE CHANGES WERE INTENDED TO REDUCE THE PROBABILITY OF A USER HAVING DIFFICULTY WITH REMOVING THE NEEDLE AFTER SENSOR INSERTION. FURTHER, THE CONNECTOR LEDGE OF THE SENOR BASE WAS INCREASED FROM 0.007" TO 0.011" TO REDUCE RELATIVEROTATIONAL MOTION BE

510(k) clearances by this applicant