Astron Pulsar Stent System, Pulsar-18 Stent System

FDA Premarket Approval P160025 S015

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

DeviceAstron Pulsar Stent System, Pulsar-18 Stent System
Generic NameStent, Superficial Femoral Artery
ApplicantBIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-21
Decision Date2022-07-27
PMAP160025
SupplementS015
Product CodeNIP 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBIOTRONIK, INC.
6024 Jean Road
lake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
addition Of Alternative Packaging Verification Testing

Supplemental Filings

Supplement NumberDateSupplement Type
P160025Original Filing
S015 2022-06-21 30-day Notice
S014 2022-04-20 30-day Notice
S013
S012 2021-09-15 30-day Notice
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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