PMA P980035S836

Device: Astra S DR MRI IPG (X3DR01);Astra S SR MRI IPG (X3SR01);Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Azur
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S836
Product code: NVZ
Decision date: 2026-05-14
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: Approval for updates to the protection diode component and associated manufacturing changes for cardiac resynchronization therapy pacemakers (CRT-Ps) and implantable pulse generators (IPGs).

Current openFDA PMA Record#

Device: Astra S DR MRI IPG (X3DR01);Astra S SR MRI IPG (X3SR01);Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Azur
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S836
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2026-05-14
Decision code: APPR
Date received: 2026-02-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to the protection diode component and associated manufacturing changes for cardiac resynchronization therapy pacemakers (CRT-Ps) and implantable pulse generators (IPGs).