FDA PMA FDA Class 3 Approved 🇺🇸 United States

Implantable Pulse Generator, Pacemaker (Non-Crt)

PMA: P900022 · Decision Sep 6, 1991
Classifications
1
FEI Numbers
35
Registration Numbers
35

Basic Information

Device Name
Implantable Pulse Generator, Pacemaker (Non-Crt)
Trade Name
CHORUS DDD PACEMAKER
PMA Number
P900022
Device Class
FDA Class 3
Product Code
LWP
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
Medical Specialty
Unknown
Advisory Committee
Cardiovascular
Decision
Approved
Decision Code
APPR
Decision Date
September 6, 1991
Date Received
April 6, 1990
Expedited Review
N
Docket Number
91M-0367

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LWP Implantable Pulse Generator, Pacemaker (Non-Crt)