PMA P180011S049

Device: ELUVIA Drug-Eluting Vascular Stent System
Applicant: Boston Scientific Corp
PMA number: P180011
Supplement: S049
Product code: NIU
Decision date: 2022-05-06
Generic name: Stent, superficial femoral artery, drug-eluting
Approval order statement: Process devices using the reduced EtO S756 sterilization cycle at the BSC Coventry Rhode Island, BSC Galway Ireland, and Steris Tullamore Ireland facilities.

Current openFDA PMA Record#

Device: ELUVIA Drug-Eluting Vascular Stent System
Applicant: Boston Scientific Corp
PMA number: P180011
Supplement: S049
Product code: NIU
Generic name: Stent, superficial femoral artery, drug-eluting
Decision date: 2022-05-06
Decision code: OK30
Date received: 2022-04-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Process devices using the reduced EtO S756 sterilization cycle at the BSC Coventry Rhode Island, BSC Galway Ireland, and Steris Tullamore Ireland facilities.