- 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
- S685
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2021-06-04
- Decision code
- OK30
- Date received
- 2021-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the Solder Paste Inspection at Medtronic Tempe Campus (MTC).