PMA P170013S012

Device: Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr
Applicant: MicroVention, Inc.
PMA number: P170013
Supplement: S012
Product code: QCA
Decision date: 2024-08-21
Classification: Neurology
Generic name: Intracranial coil-assist stent
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P170013

Current openFDA PMA Record#

Device: Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr
Applicant: MicroVention, Inc.
PMA number: P170013
Supplement: S012
Product code: QCA
Generic name: Intracranial coil-assist stent
Decision date: 2024-08-21
Decision code: APPR
Date received: 2024-03-14
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P170013