PMA P010015S438

Device
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
Applicant
Medtronic, Inc.
Product code
LWP
Decision date
2020-07-24
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for firmware updates to the MyCareLink Patient Monitor Model 24950

Current openFDA PMA Record#

Device
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
Applicant
Medtronic, Inc.
PMA number
P010015
Supplement
S438
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2020-07-24
Decision code
APPR
Date received
2020-05-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for firmware updates to the MyCareLink Patient Monitor Model 24950