ENROUTE TRANSCAROTID STENT SYSTEM

Stent, Carotid

FDA Premarket Approval P140026

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 enroute transcarotid stent system. This device is indicated for use in conjunction with the enroute transcarotid neuroprotection system (nps) for the treatment of patients at high riskfor adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. 1) patients with neurological symptoms and >= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram or patients without neurological symptoms and >=80% stenosis of the common or internal carotid artery by ultrasound or angiogram; 2) patients must have a vessel diameter of 4-9mm at the target lesion; and 3) carotid bifurcation is located at minimum 5 cm above the clavicle to allow for placement of the enroute transcarotid nps.

DeviceENROUTE TRANSCAROTID STENT SYSTEM
Classification NameStent, Carotid
Generic NameStent, Carotid
ApplicantSILK ROAD MEDICAL, INC
Date Received2014-11-17
Decision Date2015-05-18
Notice Date2015-06-02
PMAP140026
SupplementS
Product CodeNIM
Docket Number15M-1956
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address SILK ROAD MEDICAL, INC 735 North Pastoria Ave sunnyvale, CA 94085
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P140026Original Filing
S026 2022-12-08 30-day Notice
S025 2022-11-21 30-day Notice
S024
S023
S022
S021 2022-06-13 30-day Notice
S020
S019 2022-04-22 30-day Notice
S018 2021-04-05 30-day Notice
S017 2021-03-05 Special (immediate Track)
S016
S015 2020-05-18 30-day Notice
S014 2019-12-17 Normal 180 Day Track No User Fee
S013 2019-08-05 30-day Notice
S012 2019-04-05 30-day Notice
S011 2018-12-04 30-day Notice
S010 2018-04-23 Normal 180 Day Track No User Fee
S009 2018-04-02 30-day Notice
S008 2018-01-29 30-day Notice
S007
S006 2017-02-14 Normal 180 Day Track No User Fee
S005 2017-01-31 Normal 180 Day Track
S004 2017-01-09 30-day Notice
S003 2016-06-08 30-day Notice
S002 2016-03-07 Normal 180 Day Track No User Fee
S001 2015-06-05 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00811311020539 P140026 000
00811311020362 P140026 000
00811311020379 P140026 000
00811311020386 P140026 000
00811311020393 P140026 000
00811311020409 P140026 000
00811311020416 P140026 000
00811311020423 P140026 000
00811311020430 P140026 000
00811311020447 P140026 000
00811311020454 P140026 000
00811311020522 P140026 000
00811311020515 P140026 000
00811311020508 P140026 000
00811311020492 P140026 000
00811311020485 P140026 000
00811311020478 P140026 000
00811311020461 P140026 000
00811311021277 P140026 024
00811311021284 P140026 024
00811311021291 P140026 024
00811311021307 P140026 024
00811311021314 P140026 024
00811311021321 P140026 024
00811311021260 P140026 024

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