Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System

FDA Premarket Approval P170030 S024

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

DeviceOrsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantBiotronik, Inc6024 Jean Roadlake Oswego, OR 97035 PMA NumberP170030 Supplement NumberS024 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-21
Decision Date2022-07-27
PMAP170030
SupplementS024
Product CodeNIQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressBiotronik, Inc
6024 Jean Road
lake Oswego, OR 97035 PMA NumberP170030 Supplement NumberS024 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
addition Of Alternative Packaging Verification Testing

Supplemental Filings

Supplement NumberDateSupplement Type
P170030Original Filing
S026 2022-07-07 30-day Notice
S025
S024 2022-06-21 30-day Notice
S023
S022
S021 2022-01-31 30-day Notice
S020 2021-11-09 30-day Notice
S019
S018 2021-07-02 30-day Notice
S017 2021-06-14 30-day Notice
S016 2021-04-08 30-day Notice
S015 2021-03-25 30-day Notice
S014 2021-01-19 30-day Notice
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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