PMA P980035S830

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: S830
Product code: NVZ
Decision date: 2026-01-23
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: implementation for the back half of an additional battery manufacturing line for battery used in Medtronic devices

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: S830
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2026-01-23
Decision code: OK30
Date received: 2026-01-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation for the back half of an additional battery manufacturing line for battery used in Medtronic devices