Guardian Link (3) Transmitter
FDA premarket approval P160017/S008 · decided 2017-02-10
Approval details
- PMA number
- P160017
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Guardian Link (3) Transmitter
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2016-12-30
- Decision date
- 2017-02-10
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for design changes to the battery component of the GST3C transmitter. The GST3C transmitter is a component of the MiniMed 670G System.
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