PMA N970003S270

Device
Pacemaker Devices
Applicant
Boston Scientific Corp
Product code
LWP
Decision date
2022-02-24
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for a software maintenance release for updates to the Model 3300 LATITUDE Programming System software.

Current openFDA PMA Record#

Device
Pacemaker Devices
Applicant
Boston Scientific Corp
PMA number
N970003
Supplement
S270
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2022-02-24
Decision code
APPR
Date received
2021-12-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a software maintenance release for updates to the Model 3300 LATITUDE Programming System software.