DeviceClearance

Product code DTB— Cardiovascular

CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

Classification name
Permanent Pacemaker Electrode
Device class
Class 3
Regulation
21 CFR 870.3680
Advisory panel
Cardiovascular
Total cleared
487
First cleared
Most recent

Market context for product code DTB

FDA has cleared 487 devices under product code DTB between 1976 and 2006, filed by 53 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

Clearances per year

last 15 years

Top applicants under product code DTB

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 →

Recent clearances under product code DTB

1–100 of 487

Data sourced from openFDA. This site is unofficial and independent of the FDA.