PMA P090003S057

Device: Express™ LD ILIAC Premounted Stent System
Applicant: Boston Scientific Corporation
PMA number: P090003
Supplement: S057
Product code: NIO
Decision date: 2026-05-06
Classification: Cardiovascular
Generic name: STENT, ILIAC
Approval order statement: the extension of maximum transfer time between preconditioning cell to sterilization chamber during routine production for Ethylene Oxide(EtO) sterilization

Current openFDA PMA Record#

Device: Express™ LD ILIAC Premounted Stent System
Applicant: Boston Scientific Corporation
PMA number: P090003
Supplement: S057
Product code: NIO
Generic name: STENT, ILIAC
Decision date: 2026-05-06
Decision code: OK30
Date received: 2026-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the extension of maximum transfer time between preconditioning cell to sterilization chamber during routine production for Ethylene Oxide(EtO) sterilization