PMA P840068S038

Device
DELTA/VISTA PACEMAKERS
Applicant
Boston Scientific
PMA number
P840068
Supplement
S038
Product code
LWP
Decision date
1999-11-05
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for modifications to the Programmer Software Model 2881 version 1.3 and its labeling, used with the Model 2950 and Model 2901 PRM Prorammers, to correct software anomalies and update features.

Current openFDA PMA Record#

Device
DELTA/VISTA PACEMAKERS
Applicant
Boston Scientific
PMA number
P840068
Supplement
S038
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
1999-11-05
Decision code
APPR
Date received
1999-10-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for modifications to the Programmer Software Model 2881 version 1.3 and its labeling, used with the Model 2950 and Model 2901 PRM Prorammers, to correct software anomalies and update features.