Guardian Sensor (3)
FDA premarket approval P160007/S004 · decided 2018-08-16
Approval details
- PMA number
- P160007
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Guardian Sensor (3)
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2018-05-18
- Decision date
- 2018-08-16
- Days to decision
- 90 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) for the Guardian Connect System along with the addition of an alternate needle supplier.
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