PMA P110010

Device: PROMUS Element™ PLUS, PREMIER™, ELITE™ Everolimus-Eluting Platinum Chromium Coronary Stent System
Applicant: Boston Scientific Corp
PMA number: P110010
Supplement: S206
Product code: NIQ
Decision date: 2025-01-14
Generic name: Coronary drug-eluting stent
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: PROMUS Element™ PLUS, PREMIER™, ELITE™ Everolimus-Eluting Platinum Chromium Coronary Stent System
Applicant: Boston Scientific Corp
PMA number: P110010
Supplement: S213
Product code: NIQ
Generic name: Coronary drug-eluting stent
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