REBEL Platinum Chromium Coronary Stent System

Stent, Coronary

FDA Premarket Approval P130030 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

To reduce the ethylene oxide gas concentration and qualify additional process challenge devices used in the bsc2000-2 sterilization cycle

DeviceREBEL Platinum Chromium Coronary Stent System
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantBoston Scientific Corp.
Date Received2019-10-10
Decision Date2019-11-07
PMAP130030
SupplementS062
Product CodeMAF
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
P130030Original Filing
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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