Guardian Connect system / Guardian Sensor (3)
FDA premarket approval P160007/S008 · decided 2018-08-03
Approval details
- PMA number
- P160007
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Guardian Connect system / Guardian Sensor (3)
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2018-07-02
- Decision date
- 2018-08-03
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Addition of an alternative press to increase manufacturing capacity for the Guardian Sensor (3) continuous glucose monitoring sensor. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect System, and MiniMed 670G systems.
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