Atlas FDA

MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715

FDA 510(k) clearance K040676 · decided 2004-05-21

Clearance details

K-number
K040676
Device name
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
Applicant
Medtronic Minimed
Decision
Substantially Equivalent
Date received
2004-03-15
Decision date
2004-05-21
Days to decision
67 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

RecordFirmDate
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PMA approvals by this applicant

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MiniMed Go app; Simplera sensor (P160007/S058)Medtronic Minimed2026-01-23
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Simplera System (P160007/S057)Medtronic Minimed2025-12-05
Medtronic MiniMed 630G System (P150001/S110)Medtronic Minimed2025-10-16