- Device
- Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S230
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2021-10-29
- Decision code
- OK30
- Date received
- 2021-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Optimize the sterilization process parameters for P01 and P02 and propose a load change for P01.