Orsiro Sirolimus Eluting Coronary Stent System

FDA Premarket Approval P170030 S008

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

The addition of identical ultrasonic cleaning machines and updates to the cleaning parameters

DeviceOrsiro Sirolimus Eluting Coronary Stent System
Generic NameCoronary Drug-eluting Stent
ApplicantBiotronik, Inc
Date Received2020-07-22
Decision Date2020-08-20
PMAP170030
SupplementS008
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
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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