MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S— 510(k) K031917

Substantially Equivalent

Medtronic Minimed

FDA 510(k) clearance K031917 for MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S, Substantially Equivalent on 2003-08-19. Applicant: Medtronic Minimed.

Clearance details

Applicant: Medtronic Minimed
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2003-06-23
Decision date: 2003-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.