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- SCJLdt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
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Guardian Connect system
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- MEDTRONIC MINIMED
- Trade Name
- Guardian Connect system
- Generic Name
- Sensor, glucose, invasive
- Decision Date
- 3/8/2018
- Days to Decision
- 730 days
- Decision Code
- APPR
- FDA Decision
- Approval