Guardian Glucose Sensor (3)
FDA premarket approval P150001/S044 · decided 2018-06-07
Approval details
- PMA number
- P150001
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Guardian Glucose Sensor (3)
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic Minimed
- Date received
- 2018-05-11
- Decision date
- 2018-06-07
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Installation of additional equipment for the automation of the GOx patterning stage of Guardian Glucose Sensor (3) to increase production capacity. The Guardian Glucose Sensor is a component of the Minimed 630, Minimed 670, and the Guardian connect systems.
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