PALMAZ BALLOON-EXPANDABLE STENT

Stent, Renal

FDA Premarket Approval P890017 S010

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

Approval for the cordis palmaz balloon expandable stent (models p104r, p154r, p204r). The device is indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous renal angioplasty (ptra) of a de novo or restenotic lesion (= 4 mm and = 50% residual stenosis by visual estimate, >= 20 mm hg peak translesional pressure gradient, >= 10 mm hg mean translesional pressure gradient, and/or grade d dissection (a spiral shaped filling defect within the lumen of the vessel) or any dissection with significant compromise in lumen flow.

• Device: PALMAZ BALLOON-EXPANDABLE STENT
• Classification Name: Stent, Renal
• Generic Name: Stent, Renal
• Applicant: CORDIS CORP.
• Date Received: 2001-12-06
• Decision Date: 2002-07-10
• Notice Date: 2002-08-08
• PMA: P890017
• Supplement: S010
• Product Code: NIN
• Docket Number: 02M-0348
• Advisory Committee: Cardiovascular
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

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