MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL PUMP, PARADIGM REAL-TIME PUMP, AND GUARDIAN REAL-TIME MONITOR

FDA premarket approval P980022/S104 · decided 2012-03-28

Approval details

PMA number

P980022

Supplement

S104

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL PUMP, PARADIGM REAL-TIME PUMP, AND GUARDIAN REAL-TIME MONITOR

Generic name

Sensor, glucose, invasive

Applicant

Medtronic Minimed

Date received

2011-11-21

Decision date

2012-03-28

Days to decision

128 days

Decision code

APPR

Product code

MDS

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

APPROVAL TO 1) ADD THE BAYER CONTOUR LINK WIRELESS METER TO THE LIST OF METERS, IN THE LABELING, THAT CAN COMMUNICATE WITH THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K); 2) ADD THE BAYER CONTOUR NEXT LINK WIRELESS METER TO THE LIST OF METERS , IN THE LABELING, THAT CAN COMMUNICATE WITH THE PARADIGM REAL-TIME REVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), PARADIGM REAL-TIME SYSTEM (MMT-522, MMT-722, MMT-522K, MMT-722K), AND THE GUARDIAN REAL-TIME CONTINUOUS MONI

510(k) clearances by this applicant