PMA P170013S009

Device: Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X
Applicant: MicroVention, Inc.
PMA number: P170013
Supplement: S009
Product code: QCA
Decision date: 2022-06-28
Generic name: Intracranial coil-assist stent
Approval order statement: Approval to place the post-approval study titled LVIS X PAS on hold, because the sponsor does not intend to market the LVIS X and LVIS Jr. X devices in the United States at this time.

Current openFDA PMA Record#

Device: Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X
Applicant: MicroVention, Inc.
PMA number: P170013
Supplement: S009
Product code: QCA
Generic name: Intracranial coil-assist stent
Decision date: 2022-06-28
Decision code: APPR
Date received: 2022-06-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval to place the post-approval study titled LVIS X PAS on hold, because the sponsor does not intend to market the LVIS X and LVIS Jr. X devices in the United States at this time.