PMA P980035S817
- Device
- Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01)
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S817
- Product code
- NVZ
- Decision date
- 2025-08-06
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- updates to the traceability and defect marking processes for integrated circuits
Current openFDA PMA Record#
- Device
- Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01)
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S817
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2025-08-06
- Decision code
- OK30
- Date received
- 2025-07-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to the traceability and defect marking processes for integrated circuits