Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith Flex with Spi
FDA premarket approval P020018/S067 · decided 2026-04-21
Approval details
- PMA number
- P020018
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith Flex with Spi
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2026-03-24
- Decision date
- 2026-04-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- changes to the manufacturing process of the gold marker bands used in the Zenith Flex AAA, Zenith Renu, Spiral-Z Iliac Leg, and Zenith Iliac Branch stent graft systems
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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 |