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PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM

FDA premarket approval P980022/S174 · decided 2015-01-02

Approval details

PMA number
P980022
Supplement
S174
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2014-12-04
Decision date
2015-01-02
Days to decision
29 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
IMPLEMENTATION OF A NEW TOOL USED AT A CONTRACT MANUFACTURER TO SUPPORT THE BACK END TESTING OF THE ASSEMBLED MINILINK REAL-TIME TRANSMITTER (MMT-7703). THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL?]TIME SYSTEM, PARADIGMREAL?]TIME REVEL SYSTEM, GUARDIAN REAL?]TIME SYSTEM, MINILINK REAL?]TIME SYSTEM, AS WELL AS THE MINIMED 530G SYSTEM.

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RecordFirmDate
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MiniMed Quick-serter (K160860)Medtronic Minimed2016-09-22
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206)Medtronic Minimed2012-03-29
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432)Medtronic Minimed2010-07-09