MYSENTRY SYSTEM ; MYSENTRY MONITOR
FDA premarket approval P980022/S169 · decided 2014-11-26
Approval details
- PMA number
- P980022
- Supplement
- S169
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MYSENTRY SYSTEM ; MYSENTRY MONITOR
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2014-10-31
- Decision date
- 2014-11-26
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- CHANGE TO THE MOLD USED IN THE MANUFACTURING OF THE USB CONNECTOR, A COMPONENT IN THE MYSENTRY MONITOR THAT IS USED TO RECEIVE DATA FROM THE PARADIGM REAL-TIME REVEL SYSTEM.
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