CONTINUOUS GLOCOSE MONITORING SYSTEM
FDA premarket approval P980022/S071 · decided 2011-10-20
Approval details
- PMA number
- P980022
- Supplement
- S071
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONTINUOUS GLOCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2010-04-22
- Decision date
- 2011-10-20
- Days to decision
- 546 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR INCORPORATING A USB CONNECTION FOR DATA UPLOAD, CHANGING THE OPERATING TIME BEFORE RECHARGING, CHANGING TO A WEB-BASED SOFTWARE SYSTEM, AND INCORPORATING A DOCKING STATION AND CLEANING PLUG. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADENAME IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM (MMT-7745).
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