Express SD Monorail Premounted Stent System

Stent, Renal

FDA Premarket Approval P060006 S098

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

DeviceExpress SD Monorail Premounted Stent System
Classification NameStent, Renal
Generic NameStent, Renal
ApplicantBoston Scientific Corp.
Date Received2019-10-10
Decision Date2019-11-07
PMAP060006
SupplementS098
Product CodeNIN
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
P060006Original Filing
S098 2019-10-10 30-day Notice
S097 2019-06-27 30-day Notice
S096 2019-05-21 30-day Notice
S095 2018-12-03 30-day Notice
S094 2018-09-10 30-day Notice
S093 2018-08-24 30-day Notice
S092 2018-06-13 30-day Notice
S091 2018-04-06 135 Review Track For 30-day Notice
S090 2018-01-17 30-day Notice
S089 2017-11-20 30-day Notice
S088 2017-10-30 30-day Notice
S087 2017-10-02 30-day Notice
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S075 2016-06-15 Normal 180 Day Track No User Fee
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S070 0000-00-00
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