- Device
- Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG,
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S695
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2021-11-30
- Decision code
- OK30
- Date received
- 2021-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New handling tray and lid set for high power hybrids at Medtronics internal supplier, Medtronic Tempe Campus.