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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceAstron Pulsar Stent System
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBiotronik AG
Ackerstrasse 6
Bülach 8180
PMA NumberP160025
Supplement NumberS011
Date Received04/08/2021
Decision Date05/06/2021
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Modification to the ethylene oxide sterilization parameters.
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