Astron Peripheral Self-Expanding Nitinol Stent System

FDA Premarket Approval P140030 S012

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

Implementation of the reorganization of the lot release changes

DeviceAstron Peripheral Self-Expanding Nitinol Stent System
Generic NameStent, Iliac
ApplicantBIOTRONIK, INC.
Date Received2021-03-25
Decision Date2021-04-23
PMAP140030
SupplementS012
Product CodeNIO 
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
P140030Original Filing
S013 2021-04-08 30-day Notice
S012 2021-03-25 30-day Notice
S011 2019-11-04 30-day Notice
S010 2019-07-15 30-day Notice
S009
S008 2018-09-17 30-day Notice
S007 2018-04-16 30-day Notice
S006 2018-04-16 30-day Notice
S005 2017-10-11 30-day Notice
S004 2017-04-19 135 Review Track For 30-day Notice
S003 2017-02-22 30-day Notice
S002 2016-03-09 30-day Notice
S001 2016-02-11 30-day Notice

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