OSR

Pacemaker/Icd/Crt Non-Implanted Components

Product code: OSR
Device name: Pacemaker/Icd/Crt Non-Implanted Components
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA
Flag: Implant

FDA classification definition

Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OSR

Classification and pathway per current FDA publications. Data from openFDA (CC0).