PMA P950037S293
- 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
- S293
- Product code
- DXY
- Decision date
- 2026-05-28
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- introduction of the use of an alternate silicone adhesive
Current openFDA PMA Record#
- 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
- S293
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-05-28
- Decision code
- OK30
- Date received
- 2026-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of the use of an alternate silicone adhesive