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.

DevicePALMAZ BALLOON-EXPANDABLE STENT
Classification NameStent, Renal
Generic NameStent, Renal
ApplicantCORDIS CORP.
Date Received2001-12-06
Decision Date2002-07-10
Notice Date2002-08-08
PMAP890017
SupplementS010
Product CodeNIN
Docket Number02M-0348
Advisory CommitteeCardiovascular
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
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 NumberDateSupplement Type
P890017Original 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 IDPMASupp
20705032057292 P890017 015
20705032057346 P890017 015
20705032057247 P890017 015
20705032057223 P890017 015
20705032057261 P890017 015
20705032057285 P890017 015
20705032057315 P890017 015

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