iCast Covered Stent System
FDA premarket approval P120003/S011 · decided 2025-09-12
Approval details
- PMA number
- P120003
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- iCast Covered Stent System
- Generic name
- Iliac covered stent, arterial
- Applicant
- Atrium Medical Corp.
- Date received
- 2025-08-13
- Decision date
- 2025-09-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PRL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hudson, NH
- Statement
- to add an alternate testing supplier for lot release bacterial endotoxin testing
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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 |