PMA P830026S070

Device
RX5000 (TM) GRAPHICS PROGRAMMER
Applicant
Boston Scientific
PMA number
P830026
Supplement
S070
Product code
LWP
Decision date
1997-04-17
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
APPROVAL FOR THE RX5000 MODEL 522-12 VERSION 2.01.03 OPERATING SYSTEM.

Current openFDA PMA Record#

Device
RX5000 (TM) GRAPHICS PROGRAMMER
Applicant
Boston Scientific
PMA number
P830026
Supplement
S070
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
1997-04-17
Decision code
APPR
Date received
1997-03-14
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE RX5000 MODEL 522-12 VERSION 2.01.03 OPERATING SYSTEM.