PMA P980035S834

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); Az
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S834
Product code: NVZ
Decision date: 2026-04-30
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: Approval for updates to the manufacturing acceptance conditions for plated through holes in hybrid subassemblies incorporated into implantable cardiac rhythm management devices.

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); Az
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S834
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2026-04-30
Decision code: APPR
Date received: 2026-01-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to the manufacturing acceptance conditions for plated through holes in hybrid subassemblies incorporated into implantable cardiac rhythm management devices.