GUARDIAN REAL-TIME SYSTEM, PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL PUMP

FDA premarket approval P980022/S121 · decided 2012-09-13

Approval details

PMA number

P980022

Supplement

S121

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

GUARDIAN REAL-TIME SYSTEM, PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL PUMP

Generic name

Sensor, glucose, invasive

Applicant

Medtronic Minimed

Date received

2012-08-17

Decision date

2012-09-13

Days to decision

27 days

Decision code

OK30

Product code

MDS

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Northridge, CA

Statement

REINSTATEMENT OF THE AYUTTHAYA, THAILAND FACILITY AS AN ADDITIONAL FACILITY FOR THE MANUFACTURE OF PRINTED CIRCUIT BOARD ASSEMBLIES AND STACK SUBASSEMBLIES USED BY MEDTRONIC MINIMED IN THE PRODUCTION OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-523K, MMT-723, AND MMT-723K)) AND GUARDIAN REAL-TIME MONITOR (CSS7100, CSS7 100K). THE PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PU

510(k) clearances by this applicant