FDA PMA FDA Class 3 Approved 🇺🇸 United States

Implantable Pulse Generator, Pacemaker (Non-Crt)

PMA: P860027 · Decision Feb 27, 1987
Classifications
1
FEI Numbers
35
Registration Numbers
35

Basic Information

Device Name
Implantable Pulse Generator, Pacemaker (Non-Crt)
Trade Name
MAESTRO SERIES 500 P.G. MODELS 501, 505, 509
PMA Number
P860027
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
February 27, 1987
Date Received
July 28, 1986
Expedited Review
N
Docket Number
87M-0085

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)