PMA P840068S028

Device
VIGOR MODEL 2880 SOFTWARE APPLICATION
Applicant
Boston Scientific
PMA number
P840068
Supplement
S028
Product code
LWP
Decision date
1996-03-22
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
APPROVAL FOR THE USE OF THE VIGOR MODEL 2880 SOFTWARE APPLICATION USED IN CONJUNCTION WITH THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) ON THE MODEL 2950 PRM FOR PROGRAMMING OF ALL COMMERCIALLY AVAILABLE VIGOR PACEMAKERS

Current openFDA PMA Record#

Device
VIGOR MODEL 2880 SOFTWARE APPLICATION
Applicant
Boston Scientific
PMA number
P840068
Supplement
S028
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
1996-03-22
Decision code
APPR
Date received
1995-09-11
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE USE OF THE VIGOR MODEL 2880 SOFTWARE APPLICATION USED IN CONJUNCTION WITH THE MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) ON THE MODEL 2950 PRM FOR PROGRAMMING OF ALL COMMERCIALLY AVAILABLE VIGOR PACEMAKERS