PARADIGM REAL-TIME INSULIN PUMP & GUARDIAN REAL-TIME MONITOR
FDA premarket approval P980022/S049 · decided 2009-04-02
Approval details
- PMA number
- P980022
- Supplement
- S049
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PARADIGM REAL-TIME INSULIN PUMP & GUARDIAN REAL-TIME MONITOR
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2009-03-06
- Decision date
- 2009-04-02
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- CHANGE TO THE KEYPAD ASSEMBLY.
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