Atlas FDA

iPro2 System

FDA premarket approval P150029/S030 · decided 2019-08-14

Approval details

PMA number
P150029
Supplement
S030
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
iPro2 System
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2019-07-15
Decision date
2019-08-14
Days to decision
30 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Automation of an inspection method at a contract manufacturer used during the packaging of components for the MiniLink REAL-Time transmitter, Guardian Link Transmitter, Guardian Link (3) Transmitter, Guardian Connect System, and iPro2 Recorder. The MiniLink REAL-Time transmitter is a component of the Minimed 530g System, Paradigm REAL-Time Revel System, and the Paradigm REAL-Time System. The Guardian Link Transmitter is a component of the Minimed 630G Insulin Pump System. The Guardian Link (3) T

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510(k) clearances by this applicant

RecordFirmDate
SmartGuard Technology; Predictive Low Glucose Technology (K261962)Medtronic MiniMed2026-07-09
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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