PRO-Kinetic Energy Coronary Stent System

FDA Premarket Approval P160003 S014

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

A source change for an acid solution used during the stent manufacturing

DevicePRO-Kinetic Energy Coronary Stent System
Generic NameStent, Coronary
ApplicantBIOTRONIK, INC.
Date Received2021-06-14
Decision Date2021-07-13
PMAP160003
SupplementS014
Product CodeMAF 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035

Supplemental Filings

Supplement NumberDateSupplement Type
P160003Original Filing
S014 2021-06-14 30-day Notice
S013 2021-04-08 30-day Notice
S012 2021-03-25 30-day Notice
S011
S010 2020-07-09 30-day Notice
S009 2019-11-04 30-day Notice
S008 2019-05-06 30-day Notice
S007
S006 2018-06-29 135 Review Track For 30-day Notice
S005 2018-05-10 Normal 180 Day Track No User Fee
S004 2018-04-16 30-day Notice
S003
S002 2017-04-19 135 Review Track For 30-day Notice
S001 2017-02-22 30-day Notice

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