FDA PMA FDA Class 3 Approved 🇺🇸 United States

Implantable Pulse Generator, Pacemaker (Non-Crt)

PMA: P820014 · Supplement: S003 · Decision Jul 28, 1983
Classifications
1
FEI Numbers
35
Registration Numbers
35

Basic Information

Device Name
Implantable Pulse Generator, Pacemaker (Non-Crt)
Trade Name
CORDIS SEQUICOR THETA MODELS 233D & 233E
PMA Number
P820014
Supplement Number
S003
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
July 28, 1983
Date Received
April 21, 1983
Expedited Review
N

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)