PMA P890003S425

Device
Synergyst II Pulse Generator
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S425
Product code
NVZ
Decision date
2020-03-02
Generic name
Pulse generator, permanent, implantable
Approval order statement
Approval for firmware updates to the MyCareLink Patient Monitor Models 24950 and 24952.

Current openFDA PMA Record#

Device
Synergyst II Pulse Generator
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S425
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2020-03-02
Decision code
APPR
Date received
2019-12-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for firmware updates to the MyCareLink Patient Monitor Models 24950 and 24952.