DeviceClearance

K072864

Substantially Equivalent

ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM

Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
Product code
DRB
Advisory panel
Cardiovascular
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 DRB

product code DRB
Death
36
Injury
562
Total
598

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.