Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor3Product Code
- OZOAutomated Insulin Dosing , Threshold Suspend3Product Code
- OZPAutomated Insulin Dosing Device System, Single Hormonal Control3Product Code
- LHEController, Closed-Loop Blood Glucose3Product Code
- LKVEnzyme Immunoassay, Fetal Fibronectin3Product Code
- LMYMonitor, Skin Resistance/Skin Temperature, For Insulin Reactions3Product Code
- LTCHyaline Membrane Disease Assay3Product Code
- MDSSensor, Glucose, Invasive3Product Code
- P160007Guardian Connect systemAPPRPMA Approval
- P150021FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEMAPPRPMA Approval
- P150029IPRO2 CGM SYSTEM WITH ENLITE SENSORAPPRPMA Approval
- P150019PARADIGM REAL-TIME REVEL SYSTEMAPPRPMA Approval
- P120005DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEMAPPRPMA Approval
- P050020FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORAPWDPMA Approval
- P050012DEXCOM STS CONTINOUS MONITORSAPWDPMA Approval
- P980022CONTINUOUS GLUCOSE MONITORING SYSTEMAPPRPMA Approval
- MWQSystem, Test, Total Antioxidant Status3Product Code
- NCTInstrument, Glucose, Noninvasive Technology3Product Code
- NQCTest, Breath Analysis, Volatile Organic CompoundsFProduct Code
- NUKFor Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test SystemNProduct Code
- NULFor Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test SystemNProduct Code
- OTVResearch Use Only/Clinical Chemistry DevicesNProduct Code
- OZQAutomated Insulin Dosing Device System, Bihormonal Control3Product Code
- PAQTest, Nr2 AntibodyNProduct Code
- PARTest, Volatile Organic Compounds Breath AnalysisFProduct Code
- PDAInvestigational Use Only - Clinical ChemistryNProduct Code
- PEJSalivary Estriol Test3Product Code
- PHKTest, Cell Mediated Immune Response, Liver And Small Bowel Transplant/TransplantationNProduct Code
- PQFSensor, Glucose, Invasive, Non-Adjunctive3Product Code
- PZESensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated3Product Code
- QCDContinuous Glucose Monitor, Implanted, Adjunctive Use3Product Code
- QHJSensor, Glucose, Implanted, Non-Adjunctive Use3Product Code
- QRVSetmelanotide Eligibility Gene Variant Detection System2Product Code
- QWZPrognostic Test For Assessment Of Chronic Kidney Disease Progression2Product Code
- QXCDiabetes Digital Therapeutic Device2Product Code
- SBAIntegrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate2Product Code
- SCHLdt, Approved By Nys ClepNProduct Code
- SCEIvd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final RuleNProduct Code
- SCFLdt, Unmet Need Within An Integrated Healthcare SystemNProduct Code
- SCGModified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final RuleNProduct Code
- SCIIvd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
- SCJLdt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
- SFUGlucose Range Monitoring System2Product Code
- SFISensor, Glucose, Invasive, Component Of Automated Insulin Delivery System3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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Guardian Connect system
- Page Type
- PMA Approval
- 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