Innova Vascular Self-Expanding Stent System

FDA Premarket Approval P140028 S062

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

Modifying the process and aids used for stent expansion.

DeviceInnova Vascular Self-Expanding Stent System
Generic NameStent, Superficial Femoral Artery
ApplicantBOSTON SCIENTIFIC CORPORATION
Date Received2020-07-14
Decision Date2020-07-20
PMAP140028
SupplementS062
Product CodeNIP 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P140028Original Filing
S062 2020-07-14 30-day Notice
S061
S060 2020-06-05 30-day Notice
S059 2020-03-27 30-day Notice
S058 2020-03-23 30-day Notice
S057 2020-03-16 30-day Notice
S056
S055
S054 2020-01-27 30-day Notice
S053
S052 2019-12-09 30-day Notice
S051
S050
S049 2019-11-18 30-day Notice
S048 2019-11-15 30-day Notice
S047 2019-11-13 30-day Notice
S046 2019-09-30 30-day Notice
S045 2019-09-16 30-day Notice
S044
S043 2019-08-27 30-day Notice
S042
S041 2019-06-27 30-day Notice
S040 2019-05-21 30-day Notice
S039 2019-05-06 30-day Notice
S038 2019-02-04 30-day Notice
S037 2019-01-28 30-day Notice
S036 2018-12-17 Special (immediate Track)
S035 2018-11-21 30-day Notice
S034 2018-11-14 30-day Notice
S033 2018-09-19 30-day Notice
S032 2018-06-01 30-day Notice
S031
S030 2017-11-20 30-day Notice
S029 2017-10-12 30-day Notice
S028 2017-08-09 30-day Notice
S027 2017-05-30 30-day Notice
S026 2017-05-16 30-day Notice
S025 2017-04-28 30-day Notice
S024 2017-01-25 30-day Notice
S023 2016-11-22 30-day Notice
S022 2016-11-22 30-day Notice
S021 2016-11-21 Normal 180 Day Track No User Fee
S020 2016-11-02 30-day Notice
S019 2016-10-03 30-day Notice
S018 2016-08-19 30-day Notice
S017 2016-08-17 30-day Notice
S016 2016-08-05 30-day Notice
S015 2016-07-13 30-day Notice
S014 2016-05-03 30-day Notice
S013 2016-04-29 30-day Notice
S012 2016-04-11 30-day Notice
S011 2016-03-21 30-day Notice
S010 2016-03-14 Normal 180 Day Track No User Fee
S009 2016-03-11 30-day Notice
S008 2016-03-02 30-day Notice
S007 2016-02-18 30-day Notice
S006 2015-11-06 30-day Notice
S005 2015-10-19 30-day Notice
S004 2015-10-13 30-day Notice
S003 2015-09-28 30-day Notice
S002 2015-09-09 30-day Notice
S001 2015-08-19 Normal 180 Day Track No User Fee

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