PARADIGM REAL-TIME INSULIN PUMP
FDA premarket approval P980022/S041 · decided 2009-01-30
Approval details
- PMA number
- P980022
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADIGM REAL-TIME INSULIN PUMP
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2008-11-24
- Decision date
- 2009-01-30
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR A DESIGN MODIFICATION TO THE PARADIGM REAL-TIME INSULIN PUMP (MMT-551 AND MMT-722) TO CHANGE THE KEYPAD OVERLAY COLORS TO MATCH THE EXISTING COLOR OF THE PUMP CASE AND TO ADD A NEW CASE COLOR WITH MATCHING KEYPAD OVERLAY.
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510(k) clearances by this applicant
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