ORSIRO Sirolimus Eluting Coronary Stent System

FDA Premarket Approval P170030 S010

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

Changes to the sirolimus impurities and chloroform residual testing methods

DeviceORSIRO Sirolimus Eluting Coronary Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantBiotronik, Inc
Date Received2020-09-21
Decision Date2020-10-21
PMAP170030
SupplementS010
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Biotronik, Inc 6024 Jean Road lake Oswego, OR 97035

Supplemental Filings

Supplement NumberDateSupplement Type
P170030Original Filing
S013 2020-10-16 30-day Notice
S012 2020-10-16 30-day Notice
S011 2020-10-02 Normal 180 Day Track No User Fee
S010 2020-09-21 30-day Notice
S009
S008 2020-07-22 30-day Notice
S007
S006 2020-06-02 30-day Notice
S005 2019-11-04 30-day Notice
S004 2019-09-27 30-day Notice
S003 2019-04-17 Normal 180 Day Track No User Fee
S002
S001

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