PMA P980035S739
- Device
- Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S739
- Product code
- NVZ
- Decision date
- 2023-02-03
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Implement manufacturing process updates at a capacitor supplier.
Current openFDA PMA Record#
- Device
- Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S739
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2023-02-03
- Decision code
- OK30
- Date received
- 2023-01-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement manufacturing process updates at a capacitor supplier.