DeviceClearance

Product code KRG— Cardiovascular

PACEMAKER PROGRAMMER

Classification name
Programmer, Pacemaker
Device class
Class 3
Regulation
21 CFR 870.3700
Advisory panel
Cardiovascular
Total cleared
25
First cleared
Most recent

Market context for product code KRG

FDA has cleared 25 devices under product code KRG between 1977 and 1995, filed by 11 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

Top applicants under product code KRG

Adverse events under product code KRG

product code KRG
Malfunction
8,377
Total
8,377

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 KRG

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