SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003
FDA premarket approval P980022/S122 · decided 2012-09-18
Approval details
- PMA number
- P980022
- Supplement
- S122
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2012-08-23
- Decision date
- 2012-09-18
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- MANUFACTURING PROCESS CHANGE WHICH WILL INCORPORATE THE ADDITION OF PROCESS WATER TO A ONCE-DILUTED BATCH OF PLATINUM PLATING SOLUTION FOR THE SOF-SENSORGLUCOSE SENSORS (MODELS MMT-7002 AND MMT-7003) THAT ARE COMPONENTS OF THE DEVICES.
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| 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 |