- Device
- Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADVDD01, SED01, SEDR01, SES01); Adapta, Versa, Sensia IPG (SE
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S841
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-06-11
- Decision code
- OK30
- Date received
- 2026-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to reduce the epoxy dispense process dot monitoring frequency for at the Medtronic Singapore Operations site