Pacemaker/Icd/Crt Non-Implanted Components

OSR · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: OSR
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 0
Registered establishments: 34

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown