PMA P980035S818

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: S818
Product code: NVZ
Decision date: 2025-08-12
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: a supplier update to their wafer polishing washing process, new equivalent equipment, and a duplicate cleaning step in the manufacturing process flow

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: S818
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2025-08-12
Decision code: OK30
Date received: 2025-07-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a supplier update to their wafer polishing washing process, new equivalent equipment, and a duplicate cleaning step in the manufacturing process flow