PMA P170013S007
- Device
- Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
- Applicant
- MicroVention, Inc.
- PMA number
- P170013
- Supplement
- S007
- Product code
- QCA
- Decision date
- 2021-10-08
- Generic name
- Intracranial coil-assist stent
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS).
Current openFDA PMA Record#
- Device
- Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
- Applicant
- MicroVention, Inc.
- PMA number
- P170013
- Supplement
- S007
- Product code
- QCA
- Generic name
- Intracranial coil-assist stent
- Decision date
- 2021-10-08
- Decision code
- APPR
- Date received
- 2021-09-08
- 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).