PMA P030054S182

Device
CRT LEADS (MODELS 1156T, 1158Y AND 1258T).
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S182
Product code
OJX
Decision date
2011-05-11
Classification
Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement
APPROVAL FOR A DIMENSIONAL CHANGE TO THE IS-1 CONNECTOR FRONT SEAL.

Current openFDA PMA Record#

Device
CRT LEADS (MODELS 1156T, 1158Y AND 1258T).
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S182
Product code
OJX
Generic name
Drug eluting permanent left ventricular (lv) pacemaker electrode
Decision date
2011-05-11
Decision code
APPR
Date received
2011-03-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A DIMENSIONAL CHANGE TO THE IS-1 CONNECTOR FRONT SEAL.