MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P980022/S023 · decided 2008-07-17
Approval details
- PMA number
- P980022
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2007-12-14
- Decision date
- 2008-07-17
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR AN UPDATE OF SOFTWARE USED IN MODEL MMT 512 AND MMT 712 INSULIN PUMPS TO VERSION 2.2A.
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