CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P980022/S178 · decided 2015-05-19
Approval details
- PMA number
- P980022
- Supplement
- S178
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2015-02-18
- Decision date
- 2015-05-19
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR A CHANGE TO THE SHELF HEIGHT DIMENSIONS OF THE WATERTIGHT TESTER (MMT-7726), A COMPONENT OF THE MINILINK REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM AND THE MINIMED 530G SYSTEM.
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| POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432) | Medtronic Minimed | 2010-07-09 |