Zenith AAA Endovascular Graft
FDA premarket approval P020018/S059 · decided 2020-10-08
Approval details
- PMA number
- P020018
- Supplement
- S059
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zenith AAA Endovascular Graft
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2020-09-17
- Decision date
- 2020-10-08
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- Approval for the use of a Stent Orientation tool in the manufacturing of the Zenith AAA Endovascular Graft.
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 |
|---|---|---|
| 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 |