PMA P960004S112

Device: FINELINE™ II Sterox and Sterox EZ pace/sense leads
Applicant: Boston Scientific
PMA number: P960004
Supplement: S112
Product code: NVN
Decision date: 2026-02-20
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: to transfer the 100% ethylene oxide (EO) gas sterilization process for the CRM leads from BSC's Dorado, Puerto Rico site to BSC's Coventry, Rhode Island site

Current openFDA PMA Record#

Device: FINELINE™ II Sterox and Sterox EZ pace/sense leads
Applicant: Boston Scientific
PMA number: P960004
Supplement: S112
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-02-20
Decision code: APPR
Date received: 2025-12-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to transfer the 100% ethylene oxide (EO) gas sterilization process for the CRM leads from BSC's Dorado, Puerto Rico site to BSC's Coventry, Rhode Island site