- Device
- Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, Estella DR,
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S226
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2021-07-21
- Decision code
- OK30
- Date received
- 2021-06-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce incoming inspections on specified batteries, wiring bands, and resistors.