MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SOFTWARE SYSTEM
FDA premarket approval P980022/S099 · decided 2011-12-20
Approval details
- PMA number
- P980022
- Supplement
- S099
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SOFTWARE SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2011-10-21
- Decision date
- 2011-12-20
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR SOFTWARE CHANGES TO THE CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES MMT-7333 V5.7A FOR USE WITH THE MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM.
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