PMA P210030S002

Device: Roadsaver/CASPER Carotid Stent System
Applicant: MicroVention, Inc.
PMA number: P210030
Supplement: S002
Product code: NIM
Decision date: 2026-07-07
Classification: Cardiovascular
Generic name: Stent, carotid
Approval order statement: Changes include a new automated vision system as an alternate to the existing manual quality inspection process for stent measurement and a change for the delivery pusher core wire.

Current openFDA PMA Record#

Device: Roadsaver/CASPER Carotid Stent System
Applicant: MicroVention, Inc.
PMA number: P210030
Supplement: S002
Product code: NIM
Generic name: Stent, carotid
Decision date: 2026-07-07
Decision code: OK30
Date received: 2026-06-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes include a new automated vision system as an alternate to the existing manual quality inspection process for stent measurement and a change for the delivery pusher core wire.