iCast Covered Stent System
FDA premarket approval P120003/S006 · decided 2025-07-07
Approval details
- PMA number
- P120003
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- iCast Covered Stent System
- Generic name
- Iliac covered stent, arterial
- Applicant
- Atrium Medical Corp.
- Date received
- 2024-08-01
- Decision date
- 2025-07-07
- Days to decision
- 340 days
- Decision code
- APPR
- Product code
- PRL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hudson, NH
- Statement
- approval for a labeling update to reflect the use of the iCast Covered Stent System as a bridging stent between a branch vessel and an endovascular graft for treatment of patients with aneurysmal disease, limited to endovascular grafts that are approved for use with iCast
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 |
|---|---|---|
| EDRAIN CHEST DRAINAGE SYSTEM (K130131) | Atrium Medical Corp. | 2013-02-28 |
| ATRIUM FLIXENE IFG VASCULAR GRAFT (K122138) | Atrium Medical Corp. | 2012-08-17 |
| C-QUR RPM MESH (K121070) | Atrium Medical Corp. | 2012-04-26 |
| CLEARWAY RX NB CATHETER (K113112) | Atrium Medical Corp. | 2011-11-17 |
| ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (K102596) | Atrium Medical Corp. | 2010-10-05 |
| CLEARWAY OTW MODEL 85912 (K093431) | Atrium Medical Corp. | 2010-04-20 |
| ATRIUM C-QUR OVT MESH (K100076) | Atrium Medical Corp. | 2010-01-26 |
| C-QUR V -PATCH MESH (K090909) | Atrium Medical Corp. | 2009-06-04 |