Anesthesiology
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- MiscellaneousMiscellaneous
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- 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
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- 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
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- PQFSensor, Glucose, Invasive, Non-Adjunctive3Product Code
- PZESensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated3Product Code
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- QXCDiabetes Digital Therapeutic Device2Product Code
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- 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
- 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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FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Abbott Laboratories
- Trade Name
- FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR
- Generic Name
- Sensor, glucose, invasive
- Decision Date
- 3/12/2008
- Days to Decision
- 1008 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval