SOF-SENSOR GLUCOSE SENSORS
FDA premarket approval P980022/S061 · decided 2009-11-05
Approval details
- PMA number
- P980022
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOF-SENSOR GLUCOSE SENSORS
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2009-09-29
- Decision date
- 2009-11-05
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR THE REPLACEMENT OF THE CURRENT SOF-SENSOR GLUCOSE SENSOR MMT-7002 AND MMT-7003 POUCH WITH A SIMILAR ONE BY SUPPLIER TOLAS HEALTHCARE. THE DIFFERENCE BETWEEN THE TWO POUCHES IS THAT THE BOTTOM WEB OF THE POUCH IS CHANGED FROM P/N TPF-0521 TO P/N TPF-0521 NC DUE TO THE CHANGE OF THE SUPPLIER FOR TOLAS HEALTHCARE.
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