IPRO2 CGM RECORDER
FDA premarket approval P980022/S127 · decided 2013-02-20
Approval details
- PMA number
- P980022
- Supplement
- S127
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IPRO2 CGM RECORDER
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2012-11-13
- Decision date
- 2013-02-20
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR MANUFACTURING CHANGES TO THE IPRO2 RECORDER COMPONENT OF THE IPRO2 CONTINUOUS GLUCOSE MONITORING SYSTEM THAT AFFECT THE SERIAL AND MODEL NUMBER ASSIGNMENT TOOL AND THE ACCURACY TESTER DEVICE LEVEL TESTER SOFTWARE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SmartGuard Technology; Predictive Low Glucose Technology (K261962) | Medtronic MiniMed | 2026-07-09 |
| SmartGuard Technology; Predictive Low Glucose Technology (K253701) | Medtronic Minimed | 2026-02-03 |
| MiniMed Go App (K253512) | Medtronic Minimed | 2026-01-08 |
| 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 |