Atlas FDA

MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E

FDA 510(k) clearance K053177 · decided 2006-01-31

Clearance details

K-number
K053177
Device name
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
Applicant
Medtronic Minimed
Decision
Substantially Equivalent
Date received
2005-11-14
Decision date
2006-01-31
Days to decision
78 days
Clearance type
Traditional
Product code
LZG
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Northridge, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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PMA approvals by this applicant

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Guardian Connect System Simplera System (P160007/S056)Medtronic Minimed2025-10-16
Guardian Connect System (P160007/S054)Medtronic Minimed2025-10-09
Simplera System (P160007/S055)Medtronic Minimed2025-09-12
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