PMA P980016S252

Device
CONCERTO, CONCERTO2 CONSULTA AND MAXIMO 2
Applicant
Medtronic Cardiac Rhythm Disease Management
PMA number
P980016
Supplement
S252
Product code
LWS
Decision date
2010-09-29
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
APPROVAL FOR THE DESIGN CHANGES TO NPO-0402 MULTILAYER CERAMIC CAPACITORS (XC269 AND XC313).

Current openFDA PMA Record#

Device
CONCERTO, CONCERTO2 CONSULTA AND MAXIMO 2
Applicant
Medtronic Cardiac Rhythm Disease Management
PMA number
P980016
Supplement
S252
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2010-09-29
Decision code
APPR
Date received
2010-07-08
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE DESIGN CHANGES TO NPO-0402 MULTILAYER CERAMIC CAPACITORS (XC269 AND XC313).