CONTINUOUS GLUCOSE MONITORING SYSTEM SOF-SENSOR, GLUCOSE SENSORS
FDA premarket approval P980022/S095 · decided 2011-03-30
Approval details
- PMA number
- P980022
- Supplement
- S095
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONTINUOUS GLUCOSE MONITORING SYSTEM SOF-SENSOR, GLUCOSE SENSORS
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2011-03-02
- Decision date
- 2011-03-30
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- CHANGE TO USE A SEMI-AUTOMATED TAPE APPLICATION DURING SENSOR BASE ASSEMBLY.
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