PMA P980035S847

Device: Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S847
Product code: NVZ
Decision date: 2026-10-05
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: process and equipment updates of the manufacturing process of MR Delta 26H3 batteries used in Medtronic CRM devices

Current openFDA PMA Record#

Device: Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S847
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2026-10-05
Decision code: OK30
Date received: 2026-09-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: process and equipment updates of the manufacturing process of MR Delta 26H3 batteries used in Medtronic CRM devices