- 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
- S565
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2018-10-31
- Decision code
- OK30
- Date received
- 2018-10-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the silica application process by the TBC capacitor supplier.