MYSENTRY SYSTEM
FDA premarket approval P980022/S075 · decided 2011-12-20
Approval details
- PMA number
- P980022
- Supplement
- S075
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYSENTRY SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2010-05-25
- Decision date
- 2011-12-20
- Days to decision
- 574 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR THE MYSENTRY SYSTEM, WHICH INCLUDES A MONITOR/ (MMT-9101) AND A REMOTE OUTPOST (MMT-9102), FOR USE WITH THE PARADIGM REAL-TIME SYSTEM. THE NEW MANUFACTURING FACILITY FOR THE MYSENTRY SYSTEM IS FLEXTRONICS INDUSTRIAL (SHENZHEN) CO., LTD, LOCATED IN SHENZHEN, CHINA.
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