- Device
- Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Attesta DR MRl IPG; Attesta DR MRl IPG;
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S833
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-01-28
- Decision code
- OK30
- Date received
- 2026-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change of accelerometer manufacturing site and related manufacturing processes automation