PMA P840068S052

Device
DELTA / VISTA FAMILIES
Applicant
Boston Scientific
PMA number
P840068
Supplement
S052
Product code
LWP
Decision date
2012-12-05
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
REPLACE THE TRACEABILITY AND TRACKING SYSTEM.

Current openFDA PMA Record#

Device
DELTA / VISTA FAMILIES
Applicant
Boston Scientific
PMA number
P840068
Supplement
S052
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2012-12-05
Decision code
OK30
Date received
2012-11-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REPLACE THE TRACEABILITY AND TRACKING SYSTEM.