PMA P960004S113

Device: FINELINE™ II Sterox and Sterox EZ pace/sense leads
Applicant: Boston Scientific
PMA number: P960004
Supplement: S113
Product code: NVN
Decision date: 2026-03-06
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: approval for the related transfer of the downstream final packaging process from the Boston Scientific Puerto Rico Dorado site to Boston Scientific Quincy, Massachusetts facility to enable regionally co-located operations for the CRM leads.

Current openFDA PMA Record#

Device: FINELINE™ II Sterox and Sterox EZ pace/sense leads
Applicant: Boston Scientific
PMA number: P960004
Supplement: S113
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-03-06
Decision code: APPR
Date received: 2026-01-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the related transfer of the downstream final packaging process from the Boston Scientific Puerto Rico Dorado site to Boston Scientific Quincy, Massachusetts facility to enable regionally co-located operations for the CRM leads.