DeviceClearance

K001827

Substantially Equivalent

PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325

Applicant
Minimed, Inc.
Product code
FPA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sylmar, CA, US
Download summary PDF View on FDA.gov ↗

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, through . 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.