PMA P890003S482

Device: CareLink SmartSync Device Manager Base
Applicant: Medtronic, Inc.
PMA number: P890003
Supplement: S482
Product code: NVZ
Decision date: 2025-08-12
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: a supplier update to their wafer polishing washing process, new equivalent equipment, and a duplicate cleaning step in the manufacturing process flow

Current openFDA PMA Record#

Device: CareLink SmartSync Device Manager Base
Applicant: Medtronic, Inc.
PMA number: P890003
Supplement: S482
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2025-08-12
Decision code: OK30
Date received: 2025-07-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a supplier update to their wafer polishing washing process, new equivalent equipment, and a duplicate cleaning step in the manufacturing process flow