PMA P140028S070

Device: Innova Vascular Self-Expanding Stent System
Applicant: Boston Scientific Corporation
Product code: NIP
Decision date: 2021-12-23
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Approval for the introduction of a 150mm length Eluvia device, reintroduction of 180mm and 200mm Innova devices, and delivery system shaft modifications.

Current openFDA PMA Record#

Device: Innova Vascular Self-Expanding Stent System
Applicant: Boston Scientific Corporation
PMA number: P140028
Supplement: S070
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2021-12-23
Decision code: APPR
Date received: 2021-10-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the introduction of a 150mm length Eluvia device, reintroduction of 180mm and 200mm Innova devices, and delivery system shaft modifications.