CGMS IPRO SYSTEM
FDA premarket approval P980022/S028 · decided 2008-07-17
Approval details
- PMA number
- P980022
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CGMS IPRO SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2008-05-19
- Decision date
- 2008-07-17
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR THE MMT-7319 SOLUTIONS SOFTWARE FOR CGMS IPRO CONTINUOUS GLUCOSE RECORDER TO DOWNLOAD BLOOD GLUCOSE METER VALUES, OR MANUAL ENTRY OF BLOOD GLUCOSE VALUES, FROM THE LIFESCAN ULTRA 2 AND LIFESCAN ULTRALINK METERS, IN ADDITION TO THE PARADIGM LINK, LIFESCAN ULTRA AND FREESTYLE FLASH METERS.
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| InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775) | Medtronic Minimed | 2024-11-12 |
| Extended Reservoir; MiniMed Reservoir (K241622) | Medtronic Minimed | 2024-07-02 |
| MiniMed Quick-serter (K160860) | Medtronic Minimed | 2016-09-22 |
| MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206) | Medtronic Minimed | 2012-03-29 |
| 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 |