# P150029: IPRO2 CGM System with Enlite Sensor

- Pathway: PMA
- Applicant: Medtronic Minimed
- Decided: Jun 17, 2016 after 312 days
- Product code: MDS (Sensor, Glucose, Invasive)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 10, 2017 · Class II · Z-0670-2018: Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only

Source page: https://510kreport.com/device/P150029
Methodology: https://510kreport.com/methodology