ORSIRO Sirolimus Eluting Coronary Stent System

FDA Premarket Approval P170030 S011

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 of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170030

DeviceORSIRO Sirolimus Eluting Coronary Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantBiotronik, Inc
Date Received2020-10-02
Decision Date2020-10-30
PMAP170030
SupplementS011
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.