DeviceClearance

K210608

Substantially Equivalent

LUX-Dx Insertable Cardiac Monitor

Applicant
Boston Scientific Corporation
Product code
MXD
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
St Paul, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MXD

product code MXD
Injury
1,880
Malfunction
9,487
Total
11,367

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.