PALMAZ BALLOON EXPANDABLE STENT

Stent, Renal

FDA Premarket Approval P890017

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

• Device: PALMAZ BALLOON EXPANDABLE STENT
• Classification Name: Stent, Renal
• Generic Name: Stent, Renal
• Applicant: CORDIS CORP.
• Date Received: 1989-03-13
• Decision Date: 1991-09-27
• Notice Date: 1991-11-14
• PMA: P890017
• Supplement: S
• Product Code: NIN
• Docket Number: 91M-0398
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555

Supplemental Filings

Supplement Number	Date	Supplement Type
P890017		Original Filing
S023	2022-09-28	Real-time Process
S022	2021-12-08	Real-time Process
S021
S020	2019-07-23	30-day Notice
S019	2016-11-01	30-day Notice
S018	2016-03-01	135 Review Track For 30-day Notice
S017	2015-06-24	135 Review Track For 30-day Notice
S016	2015-03-17	30-day Notice
S015	2009-10-01	30-day Notice
S014	2006-01-20	Real-time Process
S013
S012
S011	2003-04-15	Normal 180 Day Track
S010	2001-12-06	Panel Track
S009	2000-05-26	Special (immediate Track)
S008	2000-03-23	Normal 180 Day Track
S007	1999-07-16	Normal 180 Day Track
S006	1998-12-31	Normal 180 Day Track
S005	1998-09-02	30-day Notice
S004	1994-02-22	Normal 180 Day Track
S003
S002	1992-04-06	Normal 180 Day Track
S001

NIH GUDID Devices

Device ID	PMA	Supp
20705032057292	P890017	015
20705032057346	P890017	015
20705032057247	P890017	015
20705032057223	P890017	015
20705032057261	P890017	015
20705032057285	P890017	015
20705032057315	P890017	015