MiniMed 670G System Pump
FDA premarket approval P160017/S043 · decided 2018-07-02
Approval details
- PMA number
- P160017
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MiniMed 670G System Pump
- Generic name
- Automated insulin dosing device system, single hormonal control
- Applicant
- Medtronic Minimed, Inc.
- Date received
- 2018-06-04
- Decision date
- 2018-07-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OZP
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Addition of a laser welding equipment for the fabrication of the drive motor assembly parts used in the MiniMed 630G Pump and the MiniMed 670G Pump, part of MiniMed 630G System with SmartGuard, and MiniMed 670G System respectively.
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510(k) clearances by this applicant
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|---|---|---|
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