PMA P030005S079

Device
INVIVE V172, V173
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S079
Product code
NKE
Decision date
2012-05-01
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 INVIVE MODELS V172, V173 PROGRAMMER 2869 APPLICATION SOFTWARE VERSION 1.07

Current openFDA PMA Record#

Device
INVIVE V172, V173
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S079
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date
2012-05-01
Decision code
APPR
Date received
2011-07-12
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR INVIVE MODELS V172, V173 PROGRAMMER 2869 APPLICATION SOFTWARE VERSION 1.07