ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Stent, Superficial Femoral Artery, Drug-eluting

FDA Premarket Approval P100022 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• Device: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Classification Name: Stent, Superficial Femoral Artery, Drug-eluting
• Generic Name: Stent, Superficial Femoral Artery, Drug-eluting
• Applicant: COOK MEDICAL INCORPORATED
• Date Received: 2012-12-11
• Decision Date: 2013-10-16
• PMA: P100022
• Supplement: S002
• Product Code: NIU
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489

Supplemental Filings

Supplement Number	Date	Supplement Type
P100022		Original Filing
S040	2021-11-04	Real-time Process
S039
S038	2021-08-11	Normal 180 Day Track No User Fee
S037	2020-11-20	30-day Notice
S036	2020-07-02	30-day Notice
S035	2020-04-16	30-day Notice
S034	2019-09-03	Special (immediate Track)
S033
S032	2018-12-26	Real-time Process
S031	2018-10-11	30-day Notice
S030	2018-10-09	Normal 180 Day Track No User Fee
S029	2018-08-09	30-day Notice
S028	2018-08-01	30-day Notice
S027	2018-05-29	Normal 180 Day Track
S026	2017-10-30	Normal 180 Day Track
S025	2017-06-01	Real-time Process
S024	2017-03-13	30-day Notice
S023	2017-03-07	30-day Notice
S022	2017-03-03	Real-time Process
S021	2016-11-18	Special (immediate Track)
S020	2016-07-05	Panel Track
S019
S018	2016-06-02	30-day Notice
S017	2016-03-15	30-day Notice
S016	2015-07-24	135 Review Track For 30-day Notice
S015	2015-07-15	Special (immediate Track)
S014	2015-06-18	Normal 180 Day Track
S013	2015-03-17	Normal 180 Day Track No User Fee
S012	2015-02-02	30-day Notice
S011	2014-11-12	Normal 180 Day Track No User Fee
S010	2014-04-17	Normal 180 Day Track No User Fee
S009	2013-09-20	30-day Notice
S008	2013-07-22	Real-time Process
S007	2013-06-24	30-day Notice
S006	2013-06-19	Special (immediate Track)
S005
S004	2012-12-13	Normal 180 Day Track No User Fee
S003	2012-12-13	Normal 180 Day Track No User Fee
S002	2012-12-11	Normal 180 Day Track
S001	2012-12-03	Normal 180 Day Track