PMA P950037S280
- Device
- Solia CSP S 53; Solia CSP S 60
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S280
- Product code
- NVN
- Decision date
- 2026-02-12
- Classification
- Cardiovascular
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Approval for the Solia CSP S pacing leads intended for implantation in the left bundle branch area.
Current openFDA PMA Record#
- Device
- Solia CSP S 53; Solia CSP S 60
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S280
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2026-02-12
- Decision code
- APPR
- Date received
- 2025-10-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Solia CSP S pacing leads intended for implantation in the left bundle branch area.