PMA P840068S026

Device
VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD
Applicant
Boston Scientific
PMA number
P840068
Supplement
S026
Product code
LWP
Decision date
1996-04-16
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE CARDIAC PACEMAKER MODELS, PELLETHANE 2363-75D POLYURETHANE WITH TECOTHANE TT1075D-M POLYURETHANE

Current openFDA PMA Record#

Device
VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD
Applicant
Boston Scientific
PMA number
P840068
Supplement
S026
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
1996-04-16
Decision code
APPR
Date received
1995-06-26
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR THE ABOVE CARDIAC PACEMAKER MODELS, PELLETHANE 2363-75D POLYURETHANE WITH TECOTHANE TT1075D-M POLYURETHANE