PMA P950037S288

Device: Solia CSP S Leads
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S288
Product code: NVN
Decision date: 2026-04-02
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: Approval of the protocol for the post-approval study (PAS) protocol to comply with the conditions of approval outlined in our approval order for P950037/S280.

Current openFDA PMA Record#

Device: Solia CSP S Leads
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S288
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-04-02
Decision code: APPR
Date received: 2026-03-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the post-approval study (PAS) protocol to comply with the conditions of approval outlined in our approval order for P950037/S280.