PMA P890003S448

Device
Reveal LINQ Application Software
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S448
Product code
NVZ
Decision date
2021-11-03
Generic name
Pulse generator, permanent, implantable
Approval order statement
Approval for an update to Reveal LINQ Application Software Model SW026.

Current openFDA PMA Record#

Device
Reveal LINQ Application Software
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S448
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2021-11-03
Decision code
APPR
Date received
2021-08-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for an update to Reveal LINQ Application Software Model SW026.