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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/Pulsar-18 Stent Systems
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBiotronik AG
Ackerstrasse 6
Bülach 8180
PMA NumberP160025
Supplement NumberS004
Date Received04/16/2018
Decision Date05/16/2018
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  
Change to replace an extrusion machine used to produce various component tubes with a new extrusion machine.
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