PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP

FDA premarket approval P980022/S146 · decided 2015-11-23

Approval details

PMA number

P980022

Supplement

S146

Supplement type

135 Review Track For 30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP

Generic name

Sensor, glucose, invasive

Applicant

Medtronic Minimed

Date received

2013-11-08

Decision date

2015-11-23

Days to decision

745 days

Decision code

APPR

Product code

MDS

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

APPROVAL FOR CHANGES IN THE WELDING PROCESS OF THE CLEAR PLASTIC WINDOW TO THE PUMP CASE OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K) AND THE MINIMED 530G INSULIN PUMP (MODEL: MMT-551). THE PARADIGM REAL-TIME INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME SYSTEM; THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME REVEL SYSTEM; AND THE MINIMED 530G INSULIN PUMP IS A PART OF TH

510(k) clearances by this applicant