PMA P880086S090

Device
AV PLUS DX, MODEL 1368
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S090
Product code
KRG
Decision date
2003-01-22
Classification
Programmer, Pacemaker
Generic name
Programmer, pacemaker
Approval order statement
APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS.

Current openFDA PMA Record#

Device
AV PLUS DX, MODEL 1368
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S090
Product code
KRG
Generic name
Programmer, pacemaker
Decision date
2003-01-22
Decision code
APPR
Date received
2002-12-04
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR EXTENDING THE SHELF LIFE OF ST. JUDE MEDICAL STEROID-ELUTING BRADYCARDIA LEADS.