IPRO2 CGM SYSTEM WITH ENLITE SENSOR
FDA premarket approval P150029 · decided 2016-06-17
Approval details
- PMA number
- P150029
- Trade name
- IPRO2 CGM SYSTEM WITH ENLITE SENSOR
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2015-08-10
- Decision date
- 2016-06-17
- Days to decision
- 312 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for the iPro2 System. This device is indicated for:The iPro2 Recorder is to be used with either Enlite sensor or Sof-Sensor and is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring device. The information collected by the iPro2 Recorder may be uploaded to a computer (with Internet access) and reviewed by healthc
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