PMA P980035S829

Device: Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01); Astra S DR MRI IPG (X3DR01); Astra S SR
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S829
Product code: NVZ
Decision date: 2026-02-10
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: to update a PLC code to correct function on the Programmable Logic Controller Software

Current openFDA PMA Record#

Device: Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01); Astra S DR MRI IPG (X3DR01); Astra S SR
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S829
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2026-02-10
Decision code: OK30
Date received: 2026-01-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to update a PLC code to correct function on the Programmable Logic Controller Software