WEB Aneurysm Embolization System
FDA premarket approval P170032/S011 · decided 2022-01-14
Approval details
- PMA number
- P170032
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WEB Aneurysm Embolization System
- Generic name
- Intrasaccular Flow Disruption Device
- Applicant
- MicroVention, Inc.
- Date received
- 2021-12-20
- Decision date
- 2022-01-14
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- OPR
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Relocation of the supplier of several WEB System components, Creganna Medical, from the manufacturing location in Tualatin, Oregon, to Wilsonville, Oregon.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Wedge XL Delivery Catheter (K232542) | MicroVention, Inc. | 2024-05-16 |
| SOFIA EX Intracranial Support Catheter (K230775) | MicroVention, Inc. | 2023-09-14 |
| EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (K222694) | MicroVention, Inc. | 2023-04-27 |
| ISAAC Neurovascular Navigation Catheter (K222115) | MicroVention, Inc. | 2023-01-10 |
| AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) (K223050) | MicroVention, Inc. | 2022-12-21 |
| SOFIA 88 Catheter (K214024) | MicroVention, Inc. | 2022-09-12 |
| ERIC Retrieval Device (K211120) | MicroVention, Inc. | 2022-03-31 |
| BOBBY Balloon Guide Catheter (K193607) | MicroVention, Inc. | 2020-07-21 |