DeviceClearance

K000029

Substantially Equivalent

STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS

Applicant
Ela Medical, Inc.
Product code
DTB
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plymouth, 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.