Epic Self-Expanding Nitinol Vascular Stent with Delivery System

FDA Premarket Approval P110035 S066

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

To automate a process used to stretch a delivery system liner material

DeviceEpic Self-Expanding Nitinol Vascular Stent with Delivery System
Generic NameStent, Iliac
ApplicantBoston Scientific Corp.
Date Received2021-03-10
Decision Date2021-04-07
PMAP110035
SupplementS066
Product CodeNIO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P110035Original Filing
S066 2021-03-10 30-day Notice
S065 2021-02-01 30-day Notice
S064 2020-12-03 30-day Notice
S063 2020-11-19 30-day Notice
S062 2020-08-21 30-day Notice
S061 2020-07-10 30-day Notice
S060
S059 2020-03-27 30-day Notice
S058 2020-03-16 30-day Notice
S057
S056
S055 2020-01-27 30-day Notice
S054 2019-11-22 30-day Notice
S053 2019-09-30 30-day Notice
S052 2019-08-14 30-day Notice
S051 2019-06-27 30-day Notice
S050 2019-05-21 30-day Notice
S049 2019-05-06 30-day Notice
S048 2018-10-09 30-day Notice
S047 2018-09-19 30-day Notice
S046 2018-06-01 30-day Notice
S045 2018-03-05 30-day Notice
S044 2017-11-20 30-day Notice
S043 2017-10-12 30-day Notice
S042 2017-09-22 Real-time Process
S041 2017-05-30 30-day Notice
S040 2017-04-28 30-day Notice
S039 2017-04-11 30-day Notice
S038 2016-10-03 30-day Notice
S037 2016-08-08 30-day Notice
S036 2016-06-15 Normal 180 Day Track No User Fee
S035 2016-06-09 135 Review Track For 30-day Notice
S034 2016-01-27 135 Review Track For 30-day Notice
S033 2015-09-09 30-day Notice
S032 2015-08-21 Normal 180 Day Track No User Fee
S031 2015-02-25 30-day Notice
S030 2015-02-05 30-day Notice
S029 2015-01-22 30-day Notice
S028 2014-07-29 30-day Notice
S027 2014-04-25 30-day Notice
S026 2014-04-24 135 Review Track For 30-day Notice
S025 2014-04-21 30-day Notice
S024 2013-11-18 30-day Notice
S023 2013-10-31 30-day Notice
S022 2013-09-27 30-day Notice
S021 2013-09-20 30-day Notice
S020 2013-09-19 30-day Notice
S019 2013-08-29 30-day Notice
S018 2013-07-17 30-day Notice
S017 2013-06-24 30-day Notice
S016 2013-06-10 30-day Notice
S015 2013-06-07 30-day Notice
S014 2013-05-09 30-day Notice
S013 2013-05-01 30-day Notice
S012 2013-03-26 Real-time Process
S011 2013-03-21 30-day Notice
S010 2013-03-11 30-day Notice
S009
S008
S007 2013-01-29 30-day Notice
S006 2013-01-28 30-day Notice
S005 2012-11-19 30-day Notice
S004 2012-10-11 30-day Notice
S003 2012-09-05 30-day Notice
S002 2012-06-13 30-day Notice
S001 2012-05-07 30-day Notice

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