- Device
- Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53; Siello S 45; Sie
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S281
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2025-12-10
- Decision code
- OK30
- Date received
- 2025-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to introduce fractal iridium coating of pacing lead components at BIOTRONIK APM