FDA.reportPublic FDA data

PMA P890003S487

Device
CareLink SmartSync Device Manager Base (24970A)
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S487
Product code
NVZ
Decision date
2026-07-31
Classification
Cardiovascular
Generic name
Pulse generator, permanent, implantable
Approval order statement
to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.

Current openFDA PMA Record#

Device
CareLink SmartSync Device Manager Base (24970A)
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S487
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2026-07-31
Decision code
OK30
Date received
2026-07-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.