FDA.reportPublic FDA data

PMA P010015S430

Device
CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol
Applicant
Medtronic, Inc.
Product code
LWP
Decision date
2020-05-17
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for CareLink SmartSync Common Application version 3.2.01, CareLink SmartSync Azure Astra Application version 3.2.02, CareLink SmartSync Percepta Serena Solara Application version 3.2.02.

Current openFDA PMA Record#

Device
CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol
Applicant
Medtronic, Inc.
PMA number
P010015
Supplement
S430
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2020-05-17
Decision code
APPR
Date received
2020-02-28
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for CareLink SmartSync Common Application version 3.2.01, CareLink SmartSync Azure Astra Application version 3.2.02, CareLink SmartSync Percepta Serena Solara Application version 3.2.02.