PMA P890003S350

Device
CareLink Programmer (Model 2090), Encore Programmer (Model 29901)
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S350
Product code
OSR
Decision date
2016-04-28
Classification
Pacemaker/icd/crt Non-implanted Components
Generic name
Pacemaker/icd/crt non-implanted components
Approval order statement
Approval for software changes to the Reveal LINQ FullView Application Software.

Current openFDA PMA Record#

Device
CareLink Programmer (Model 2090), Encore Programmer (Model 29901)
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S350
Product code
OSR
Generic name
Pacemaker/icd/crt non-implanted components
Decision date
2016-04-28
Decision code
APPR
Date received
2016-03-17
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software changes to the Reveal LINQ FullView Application Software.