PMA P140028S085

Device: Innova™ Vascular Self-Expanding Stent System
Applicant: Boston Scientific Corporation
PMA number: P140028
Supplement: S085
Product code: NIP
Decision date: 2026-05-06
Classification: Cardiovascular
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
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: Innova™ Vascular Self-Expanding Stent System
Applicant: Boston Scientific Corporation
PMA number: P140028
Supplement: S085
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
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