SEN-SERTER
FDA premarket approval P980022/S171 · decided 2014-12-03
Approval details
- PMA number
- P980022
- Supplement
- S171
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SEN-SERTER
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2014-11-03
- Decision date
- 2014-12-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- CHANGE IN THE CURING TIME DURING THE MANUFACTURING PROCESS FOR THE SENSERTER, WHICH IS A COMPONENT OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVELSYSTEM, GUARDIAN REAL-TIME CGM SYSTEM, MINILINK REAL-TIME SYSTEM, AND IPRO2PROFESSIONAL CGM SYSTEM.
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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 |