FDA.reportPublic FDA data

PMA P010015S428

Device
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola
Applicant
Medtronic, Inc.
Product code
NVZ
Decision date
2020-05-15
Generic name
Pulse generator, permanent, implantable
Approval order statement
Approval for a firmware update for MyCareLink Patient Monitor Models 24950 and 24952 to version M12.0 as well as CareLink Network updates to provide remote monitoring support for Micra AV.

Current openFDA PMA Record#

Device
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola
Applicant
Medtronic, Inc.
PMA number
P010015
Supplement
S428
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2020-05-15
Decision code
APPR
Date received
2020-02-21
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a firmware update for MyCareLink Patient Monitor Models 24950 and 24952 to version M12.0 as well as CareLink Network updates to provide remote monitoring support for Micra AV.