PMA P980035S651

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.
Product code: NVZ
Decision date: 2020-10-28
Generic name: Pulse generator, permanent, implantable
Approval order statement: Add an alternate supplier for the cathode current collector component used in the manufacture of batteries and establish associated incoming inspection procedures.

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: S651
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2020-10-28
Decision code: OK30
Date received: 2020-10-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add an alternate supplier for the cathode current collector component used in the manufacture of batteries and establish associated incoming inspection procedures.