DeviceClearance

K894040

Substantially Equivalent

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR

Applicant
Medtronic Vascular
Product code
DTB
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DTB

product code DTB
Death
1,491
Injury
67,311
Malfunction
79,368
Other
10
Total
148,180

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.