Medtronic MiniMed 530G System
FDA premarket approval P120010/S135 · decided 2019-11-04
Approval details
- PMA number
- P120010
- Supplement
- S135
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Medtronic MiniMed 530G System
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2019-10-11
- Decision date
- 2019-11-04
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Packaging, labeling, and final release activities of the One-Press Serter conducted at Medtronic, Inc. to be moved to contract manufacturer facility. The One-Press Serter is a component of the 530G System, the 630G System, the 670G System, and the Guardian Connect System.
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