iPro2 CGM System with Enlite Sensor
FDA premarket approval P150029/S016 · decided 2018-03-07
Approval details
- PMA number
- P150029
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- iPro2 CGM System with Enlite Sensor
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2018-02-09
- Decision date
- 2018-03-07
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for a minor design change to the introducer needle component of the Guardian Sensor (3) and the Enlite Sensor and the addition of an alternate needle supplier.
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