Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
FDA premarket approval P170013/S002 · decided 2018-10-06
Approval details
- PMA number
- P170013
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
- Generic name
- Intracranial coil-assist stent
- Applicant
- MicroVention, Inc.
- Date received
- 2018-09-06
- Decision date
- 2018-10-06
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- QCA
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for a revision to the Instructions for Use to add a Precaution related to the use of magnetic resonance angiography (MRA) for follow up assessment following treatment with the LVIS and LVIS Jr. devices and a revision to the symbols in the Instructions for Use and the package labeling to align these symbols with the current FDA recognized standard.
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| ERIC Retrieval Device (K211120) | MicroVention, Inc. | 2022-03-31 |
| BOBBY Balloon Guide Catheter (K193607) | MicroVention, Inc. | 2020-07-21 |