MiniMed 670G System/ Guardian Sensor (3)
FDA premarket approval P160017/S016 · decided 2017-10-16
Approval details
- PMA number
- P160017
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MiniMed 670G System/ Guardian Sensor (3)
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2017-07-21
- Decision date
- 2017-10-16
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for minor design changes to automate the manufacturing of the Adhesive Disk and the Needle-Hub assembly. In addition, approval to transfer the manufacture of the Guardian Sensor (3) from the Northridge, California facility to Medtronics Juncos, Puerto Rico facility.
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