FDA product code OSR

Pacemaker/Icd/Crt Non-Implanted Components

Unknown·Class 3·21 CFR ·Implantable
US regulatory classifications
US Product Code (FDA)
OSR
View Product Code Classification →
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
View CFR Regulation →
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

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

Search keywords
About this record

Pacemaker/Icd/Crt Non-Implanted Components is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.