PMA P980035S832
- Device
- Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S832
- Product code
- NVZ
- Decision date
- 2026-02-12
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- manufacturing and test process improvements 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
- S832
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-02-12
- Decision code
- OK30
- Date received
- 2026-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing and test process improvements for integrated circuits