CGMS IPRO CONTINUOUS GLOCOSE MONITORING SYSTEM
FDA premarket approval P980022/S047 · decided 2009-04-06
Approval details
- PMA number
- P980022
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CGMS IPRO CONTINUOUS GLOCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2009-02-09
- Decision date
- 2009-04-06
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR A MODIFICATION TO THE SOLUTIONS SOFTWARE FOR THE CGMS IPRO CONTINUOUS GLUCOSE RECORDER (MMT-7319) TO ADD AN AUTO DETECT FEATURE TO ALLOW THE SOFTWARE TO AUTOMATICALLY RECOGNIZE THE COMPUTER¿S ACTIVE PORTS AND TO CORRECT PREVIOUSLY IDENTIFIED ANOMALIES.
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