PMA P180011S065

Device: ELUVIA™ Drug-Eluting Vascular Stent System
Applicant: Boston Scientific Corp
PMA number: P180011
Supplement: S065
Product code: NIU
Decision date: 2025-01-14
Classification: Cardiovascular
Generic name: Stent, superficial femoral artery, drug-eluting
Approval order statement: the introduction of new Ethylene Oxide (EtO) sterilization chambers using existing cycles at the in-house sterilization facility in Galway, Ireland

Current openFDA PMA Record#

Device: ELUVIA™ Drug-Eluting Vascular Stent System
Applicant: Boston Scientific Corp
PMA number: P180011
Supplement: S065
Product code: NIU
Generic name: Stent, superficial femoral artery, drug-eluting
Decision date: 2025-01-14
Decision code: OK30
Date received: 2024-12-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the introduction of new Ethylene Oxide (EtO) sterilization chambers using existing cycles at the in-house sterilization facility in Galway, Ireland