Zenith® Iliac Branch
FDA premarket approval P020018/S064 · decided 2025-05-30
Approval details
- PMA number
- P020018
- Supplement
- S064
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zenith® Iliac Branch
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2024-08-01
- Decision date
- 2025-05-30
- Days to decision
- 302 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- Approval for the Zenith Iliac Branch. The Zenith Iliac Branch, when used with the necessary additional components (Zenith AAA devices and a covered bridging stent), is indicated for endovascular treatment of aortoiliac or iliac aneurysms to preserve internal iliac arterial blood flow when the distal sealing site in the common iliac artery is insufficient for the AAA device alone and when the vessel morphology is suitable for repair: 1) Common iliac artery diameter at the level of the internal il
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER (K133130) | Cook, Inc. | 2015-01-09 |
| ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE (K140593) | Cook, Inc. | 2014-12-15 |
| FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (K132592) | Cook, Inc. | 2014-10-09 |
| CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY (K133597) | Cook, Inc. | 2014-04-18 |
| CANTATA(R) 2.9 MICROCATHETER (K131772) | Cook, Inc. | 2014-02-20 |
| ADVANCE CS CORONARY SINUS INFUSION CATHETER (K131204) | Cook, Inc. | 2014-01-29 |
| SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (K133634) | Cook, Inc. | 2013-12-23 |
| ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (K132020) | Cook, Inc. | 2013-10-25 |