Orsiro Sirolimus Eluting Coronary Stent System

FDA Premarket Approval P170030 S006

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

Test procedure updates by the drug supplier of the sirolimus used for the orsiro sirolimus eluting coronary stent system

DeviceOrsiro Sirolimus Eluting Coronary Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantBiotronik, Inc
Date Received2020-06-02
Decision Date2020-06-15
PMAP170030
SupplementS006
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
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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