PMA P030005S086

Device
INVIVE CRT-P AND ZOOMVIEW PROGRAMMER
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S086
Product code
NKE
Decision date
2012-08-29
Classification
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement
APPROVAL FOR MODEL 2869 ZOOMVIEW PROGRAMMER SOFTWARE APPLICATION V1.08

Current openFDA PMA Record#

Device
INVIVE CRT-P AND ZOOMVIEW PROGRAMMER
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S086
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date
2012-08-29
Decision code
APPR
Date received
2012-07-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODEL 2869 ZOOMVIEW PROGRAMMER SOFTWARE APPLICATION V1.08