ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT

FDA Premarket Approval P140016

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the zenith alpha thoracic endovascular graft. This device is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair, including:1) iliac/femoral anatomy that is suitable for access with the required introduction systems; and2) nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion:a) with a length of at least 20 mm; andb) with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.

• Device: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
• Generic Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Applicant: COOK MEDICAL INCORPORATED
• Date Received: 2014-08-13
• Decision Date: 2015-09-15
• Notice Date: 2015-10-15
• PMA: P140016
• Supplement: S
• Product Code: MIH
• Docket Number: 15M-3377
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P140016		Original Filing
S005	2022-03-18	Special (immediate Track)
S004	2021-12-03	Special (immediate Track)
S003	2021-06-11	30-day Notice
S002	2020-10-29	Normal 180 Day Track No User Fee
S001	2017-06-28	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
10827002353937	P140016	000
10827002353692	P140016	000
10827002353685	P140016	000
10827002353678	P140016	000
10827002353661	P140016	000
10827002353654	P140016	000
10827002353647	P140016	000
10827002353630	P140016	000
10827002353623	P140016	000
10827002353616	P140016	000
10827002353609	P140016	000
10827002353593	P140016	000
10827002353586	P140016	000
10827002353708	P140016	000
10827002353715	P140016	000
10827002353722	P140016	000
10827002353920	P140016	000
10827002353913	P140016	000
10827002353869	P140016	000
10827002353852	P140016	000
10827002353845	P140016	000
10827002353838	P140016	000
10827002353821	P140016	000
10827002353814	P140016	000
10827002353760	P140016	000
10827002353753	P140016	000
10827002353746	P140016	000
10827002353739	P140016	000
10827002353579	P140016	000
10827002353562	P140016	000
10827002353555	P140016	000
10827002353395	P140016	000
10827002353388	P140016	000
10827002353371	P140016	000
10827002353364	P140016	000
10827002353357	P140016	000
10827002353340	P140016	000
10827002353333	P140016	000
10827002353326	P140016	000
10827002353319	P140016	000
10827002353302	P140016	000
10827002353296	P140016	000
10827002353289	P140016	000
10827002353401	P140016	000
10827002353418	P140016	000
10827002353425	P140016	000
10827002353548	P140016	000
10827002353531	P140016	000
10827002353524	P140016	000
10827002353517	P140016	000
10827002353500	P140016	000
10827002353494	P140016	000
10827002353487	P140016	000
10827002353470	P140016	000
10827002353463	P140016	000
10827002353456	P140016	000
10827002353449	P140016	000
10827002353432	P140016	000
10827002353272	P140016	000
10827002353944	P140016	000
10827002382364	P140016	000
10827002380728	P140016	000
10827002380551	P140016	000
10827002380414	P140016	000
10827002380285	P140016	000
10827002380278	P140016	000
10827002380254	P140016	000
10827002380247	P140016	000
10827002380230	P140016	000
10827002363462	P140016	000
10827002355269	P140016	000
10827002355252	P140016	000
10827002355245	P140016	000
10827002380759	P140016	000
10827002381718	P140016	000
10827002381725	P140016	000
10827002382203	P140016	000
10827002382166	P140016	000
10827002382081	P140016	000
10827002382043	P140016	000
10827002382036	P140016	000
10827002382012	P140016	000
10827002381916	P140016	000
10827002381909	P140016	000
10827002381800	P140016	000
10827002381794	P140016	000
10827002381787	P140016	000
10827002381732	P140016	000
10827002355238	P140016	000
10827002355221	P140016	000
10827002355214	P140016	000
10827002355047	P140016	000
10827002355030	P140016	000
10827002355023	P140016	000
10827002354040	P140016	000
10827002354033	P140016	000
10827002354026	P140016	000
10827002354019	P140016	000
10827002354002	P140016	000
10827002353999	P140016	000
10827002353982	P140016	000
10827002353975	P140016	000
10827002353968	P140016	000
10827002355054	P140016	000
10827002355061	P140016	000
10827002355078	P140016	000
10827002355207	P140016	000
10827002355191	P140016	000
10827002355184	P140016	000
10827002355177	P140016	000
10827002355160	P140016	000
10827002355153	P140016	000
10827002355146	P140016	000
10827002355139	P140016	000
10827002355122	P140016	000
10827002355115	P140016	000
10827002355108	P140016	000
10827002355092	P140016	000
10827002353951	P140016	000