Rebel Platinum Chromium Coronary Stent System (Monorail)

Stent, Coronary

FDA Premarket Approval P130030 S049

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 design changes to the stent delivery catheter, including corresponding changes to the product labeling, and removal of the accessory package from the product packaging.

DeviceRebel Platinum Chromium Coronary Stent System (Monorail)
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantBoston Scientific Corp.
Date Received2018-02-20
Decision Date2018-05-21
PMAP130030
SupplementS049
Product CodeMAF
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P130030Original Filing
S074 2022-10-17 30-day Notice
S073 2022-01-28 30-day Notice
S072 2021-02-26 30-day Notice
S071 2020-11-20 30-day Notice
S070 2020-08-07 30-day Notice
S069 2020-06-05 30-day Notice
S068 2020-03-30 30-day Notice
S067
S066 2020-02-11 30-day Notice
S065 2019-12-13 30-day Notice
S064 2019-11-22 30-day Notice
S063 2019-11-01 30-day Notice
S062 2019-10-10 30-day Notice
S061 2019-06-27 30-day Notice
S060 2019-05-21 30-day Notice
S059 2019-02-01 30-day Notice
S058 2018-12-21 30-day Notice
S057 2018-11-16 30-day Notice
S056 2018-10-05 30-day Notice
S055 2018-08-24 30-day Notice
S054 2018-08-17 30-day Notice
S053 2018-08-01 30-day Notice
S052 2018-06-13 30-day Notice
S051 2018-04-23 30-day Notice
S050 2018-04-06 135 Review Track For 30-day Notice
S049 2018-02-20 Normal 180 Day Track
S048 2018-01-17 30-day Notice
S047 2017-11-20 30-day Notice
S046 2017-10-30 30-day Notice
S045 2017-10-02 30-day Notice
S044 2017-08-18 30-day Notice
S043 2017-08-04 30-day Notice
S042 2017-07-18 30-day Notice
S041 2017-06-26 30-day Notice
S040 2017-05-05 Real-time Process
S039 2017-04-13 30-day Notice
S038 2017-04-11 30-day Notice
S037 2017-03-06 30-day Notice
S036 2016-12-15 Real-time Process
S035 2016-11-30 Normal 180 Day Track No User Fee
S034 2016-11-23 30-day Notice
S033 2016-11-22 30-day Notice
S032 2016-11-14 30-day Notice
S031 2016-10-04 Real-time Process
S030 2016-09-01 30-day Notice
S029
S028 2016-08-08 30-day Notice
S027 2016-08-01 30-day Notice
S026 2016-07-21 30-day Notice
S025 2016-07-15 30-day Notice
S024 2016-04-13 30-day Notice
S023 2016-03-21 135 Review Track For 30-day Notice
S022 2016-02-22 30-day Notice
S021 2016-02-18 30-day Notice
S020 2016-01-28 30-day Notice
S019 2016-01-20 Real-time Process
S018 2016-01-15 30-day Notice
S017 2015-09-25 135 Review Track For 30-day Notice
S016 2015-08-04 30-day Notice
S015 2015-06-09 30-day Notice
S014 2015-06-08 30-day Notice
S013
S012 2015-04-29 30-day Notice
S011 2015-03-13 30-day Notice
S010 2015-02-23 30-day Notice
S009 2015-01-26 30-day Notice
S008 2014-12-19 30-day Notice
S007 2014-12-08 Normal 180 Day Track No User Fee
S006 2014-09-30 30-day Notice
S005 2014-09-26 30-day Notice
S004 2014-09-22 30-day Notice
S003 2014-08-22 30-day Notice
S002 2014-07-28 30-day Notice
S001 2014-07-08 30-day Notice

NIH GUDID Devices

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