CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSOR MMT-7002
FDA premarket approval P980022/S076 · decided 2010-11-17
Approval details
- PMA number
- P980022
- Supplement
- S076
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONTINUOUS GLUCOSE MONITORING SYSTEM, SOF-SENSOR MMT-7002
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2010-06-07
- Decision date
- 2010-11-17
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR THE MODIFICATIONS OF THE COATING PROCESS FROM THE SPIN COATING PROCESS TO THE SLOT COATING PROCESS, AND THE ADHESION PROMOTER (AP) SOLUTION.
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