PMA P980035S822

Device: Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S822
Product code: NVZ
Decision date: 2025-10-02
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: implementing a rework process for titanium button placement in medium-rate batteries

Current openFDA PMA Record#

Device: Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S822
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2025-10-02
Decision code: OK30
Date received: 2025-09-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementing a rework process for titanium button placement in medium-rate batteries