- Device
- Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, SED01, SES01, SESR01), Adapta, Versa, Sensia IPG (SED
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S846
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-07-31
- Decision code
- OK30
- Date received
- 2026-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementing a rework process for selected seam weld defects in nEw3 model 263 devices