PMA P890003S253

Device
MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S253
Product code
KRG
Decision date
2013-01-29
Classification
Programmer, Pacemaker
Generic name
Programmer, pacemaker
Approval order statement
APPROVAL FOR THE VIVA/BRAVA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION (CRT-D).

Current openFDA PMA Record#

Device
MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S253
Product code
KRG
Generic name
Programmer, pacemaker
Decision date
2013-01-29
Decision code
APPR
Date received
2012-07-05
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE VIVA/BRAVA IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION (CRT-D).