Clearance Summary
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 received FDA 510(k) clearance under submission number K040676, sponsored by Medtronic Minimed. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2004-05-21.
- Submission: K040676
- Applicant / Sponsor: Medtronic Minimed
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2004-05-21
Classification & Regulation
This clearance is catalogued under FDA product code LZG and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.