Atlas FDA

iPro2 CGM System with Enlite Sensor

FDA premarket approval P150029/S022 · decided 2018-11-14

Approval details

PMA number
P150029
Supplement
S022
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
iPro2 CGM System with Enlite Sensor
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2018-10-15
Decision date
2018-11-14
Days to decision
30 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Manufacturing facility move at one of Medtronics tier one supplier for the manual needle-hub assembly and one-press serter base component. The one-press serter is a component of the Enlite Sensor and Guardian Sensor (3). The needle-hub assembly component is used in the Medtronic Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of the Medtronic MiniMed 530G, 630G with SmartGuard, Paradigm Real-Time Revel System and iPro2 Continuous Glucose Monitoring Systems and Guardia

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

510(k) clearances by this applicant

RecordFirmDate
SmartGuard Technology; Predictive Low Glucose Technology (K261962)Medtronic MiniMed2026-07-09
SmartGuard Technology; Predictive Low Glucose Technology (K253701)Medtronic Minimed2026-02-03
MiniMed Go App (K253512)Medtronic Minimed2026-01-08
InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775)Medtronic Minimed2024-11-12
Extended Reservoir; MiniMed Reservoir (K241622)Medtronic Minimed2024-07-02
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