PMA P950037S233
- Device
- Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S233
- Product code
- DXY
- Decision date
- 2022-03-04
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for updated labeling for Siello Pacing Leads based on final post approval study results.
Current openFDA PMA Record#
- Device
- Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S233
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2022-03-04
- Decision code
- APPR
- Date received
- 2022-01-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling for Siello Pacing Leads based on final post approval study results.