PMA P180011S055

Device: ELUVIA™ Drug-Eluting Vascular Stent System
Applicant: Boston Scientific Corp
PMA number: P180011
Supplement: S055
Product code: NIU
Decision date: 2024-01-19
Classification: Cardiovascular
Generic name: Stent, superficial femoral artery, drug-eluting
Approval order statement: Approval of introduction of the S756 Ethylene Oxide (EtO) sterilization cycle at Synergy Sterilization (M) Sdn Bhd1 located in Kuala Ketil, Malaysia

Current openFDA PMA Record#

Device: ELUVIA™ Drug-Eluting Vascular Stent System
Applicant: Boston Scientific Corp
PMA number: P180011
Supplement: S055
Product code: NIU
Generic name: Stent, superficial femoral artery, drug-eluting
Decision date: 2024-01-19
Decision code: APPR
Date received: 2023-06-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of introduction of the S756 Ethylene Oxide (EtO) sterilization cycle at Synergy Sterilization (M) Sdn Bhd1 located in Kuala Ketil, Malaysia