ENROUTE Transcarotid Stent System

FDA Premarket Approval P140026 S015

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

Updates to the software and mechanical components of the control system for vessel 2 and vessel 4 at the steris, el paso, tx ethylene oxide sterilization facility

DeviceENROUTE Transcarotid Stent System
Generic NameStent, Carotid
ApplicantSILK ROAD MEDICAL, INC
Date Received2020-05-18
Decision Date2020-06-01
PMAP140026
SupplementS015
Product CodeNIM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SILK ROAD MEDICAL, INC 735 North Pastoria Ave sunnyvale, CA 94085

Supplemental Filings

Supplement NumberDateSupplement Type
P140026Original Filing
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
00811311020522 P140026 000
00811311020515 P140026 000
00811311020508 P140026 000
00811311020492 P140026 000
00811311020485 P140026 000
00811311020478 P140026 000
00811311020461 P140026 000
00811311020454 P140026 000
00811311020447 P140026 000
00811311020430 P140026 000
00811311020423 P140026 000
00811311020416 P140026 000
00811311020409 P140026 000
00811311020393 P140026 000
00811311020386 P140026 000
00811311020379 P140026 000
00811311020539 P140026 000
00811311020362 P140026 000
00811311020522 P140026 000
00811311020515 P140026 000
00811311020508 P140026 000
00811311020492 P140026 000
00811311020485 P140026 000
00811311020478 P140026 000
00811311020461 P140026 000
00811311020454 P140026 000
00811311020447 P140026 000
00811311020430 P140026 000
00811311020423 P140026 000
00811311020416 P140026 000
00811311020409 P140026 000
00811311020393 P140026 000
00811311020386 P140026 000
00811311020379 P140026 000
00811311020362 P140026 000

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