IPRO2 CGM System with Enlite Sensor
PMA P150029
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP150029 | Date17 Jun 2016 | StatusActive |
Recalls
-
- Terminated 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 to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic name
- Sensor, glucose, invasive
- PMA number
- FDA product code
- MDS
- Device class
- Class III
- Advisory committee
- Clinical Chemistry
- FDA decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The iPro2 CGM System with Enlite Sensor is a Class III invasive glucose sensor designed for continuous monitoring of interstitial glucose levels in individuals with diabetes mellitus. It provides supplementary glucose data to standard invasive measurements, enabling healthcare professionals to review patterns of glucose excursions over time.
This system is intended for occasional, non-real-time use under prescription only, with data available for physician review up to 144 hours post-recording. The device is not intended for direct patient access or as a replacement for standard glucose monitoring. Authorized under FDA PMA (P150029), it operates as a standalone recorder compatible with the Enlite sensor, adhering to regulatory requirements for Class III medical devices.
Other devices from Medtronic Minimed, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the iPro2 CGM System with Enlite Sensor, and how does it differ from standard glucose monitoring methods?
The iPro2 CGM System with Enlite Sensor is designed for occasional, non-real-time continuous monitoring of interstitial glucose levels in individuals with diabetes mellitus. Unlike standard invasive glucose monitoring (e.g., fingerstick tests), it provides supplementary data to help healthcare professionals analyze glucose patterns over time—up to 144 hours post-recording. It is not intended for direct patient access or as a replacement for standard glucose monitoring, but rather as a tool for physicians to review trends and adjust therapies accordingly.
Is the iPro2 System intended for daily use, or is it meant for specific clinical scenarios?
The iPro2 System is explicitly designed for occasional use, not everyday monitoring. Its intended purpose is to supplement standard glucose measurements in clinical settings where healthcare professionals need to assess glucose trends over an extended period (up to six days). It is not meant for continuous, real-time patient monitoring or as a standalone solution for diabetes management.
How is the iPro2 System supplied, and can it be used with other sensors besides the Enlite?
The iPro2 System is supplied as a standalone recorder paired with the Enlite sensor (as specified in the trade name). While the regulatory data mentions compatibility with the Sof-Sensor in the advisory committee description, the iPro2 CGM System with Enlite Sensor specifically refers to the Enlite sensor as its primary component. Always verify sensor compatibility with the manufacturer’s instructions to ensure proper functionality.
What regulatory pathway was followed for the approval of the iPro2 CGM System, and what class does it belong to?
The iPro2 CGM System with Enlite Sensor is classified as a Class III medical device under FDA regulations and was approved via the Premarket Approval (PMA) pathway, with PMA number P150029. This classification reflects its invasive nature and the need for rigorous pre-market evaluation to ensure safety and effectiveness for continuous glucose monitoring in clinical settings.