PMA P980035S842

Device: Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S842
Product code: NVZ
Decision date: 2026-07-01
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: updates to the Pressure Sensitive Adhesive (PSA) monitoring process

Current openFDA PMA Record#

Device: Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S842
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2026-07-01
Decision code: OK30
Date received: 2026-06-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to the Pressure Sensitive Adhesive (PSA) monitoring process