PMA P050019S043

Device: Carotid Wallstent™ Monorail™ Endoprosthesis
Applicant: Boston Scientific Corp
PMA number: P050019
Supplement: S043
Product code: NIM
Decision date: 2025-09-19
Classification: Cardiovascular
Generic name: Stent, carotid
Approval order statement: approval for changes to the manufacturing process intended to increase the potential for consistently producing an inner guidewire lumen within the specified height

Current openFDA PMA Record#

Device: Carotid Wallstent™ Monorail™ Endoprosthesis
Applicant: Boston Scientific Corp
PMA number: P050019
Supplement: S043
Product code: NIM
Generic name: Stent, carotid
Decision date: 2025-09-19
Decision code: APPR
Date received: 2025-08-21
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for changes to the manufacturing process intended to increase the potential for consistently producing an inner guidewire lumen within the specified height