PMA P980035S843

Device: Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S843
Product code: NVZ
Decision date: 2026-07-16
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: approval of new burn-in equipment and process for electrical testing of capacitors

Current openFDA PMA Record#

Device: Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S843
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2026-07-16
Decision code: OK30
Date received: 2026-06-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of new burn-in equipment and process for electrical testing of capacitors