Astron Pulsar Stent System and Pulsar-18 Stent System

FDA Premarket Approval P160025 S010

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 Pulsar Stent System and Pulsar-18 Stent System
Generic NameStent, Superficial Femoral Artery
ApplicantBIOTRONIK, INC.
Date Received2021-03-25
Decision Date2021-04-23
PMAP160025
SupplementS010
Product CodeNIP 
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
P160025Original Filing
S011 2021-04-08 30-day Notice
S010 2021-03-25 30-day Notice
S009 2019-11-04 30-day Notice
S008 2019-07-15 30-day Notice
S007
S006 2018-07-10 30-day Notice
S005 2018-06-21 Normal 180 Day Track No User Fee
S004 2018-04-16 30-day Notice
S003 2017-10-11 30-day Notice
S002 2017-06-14 Normal 180 Day Track No User Fee
S001 2017-04-19 135 Review Track For 30-day Notice

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