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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 System
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBiotronik AG
Ackerstrasse 6
Bülach 8180
PMA NumberP160025
Supplement NumberS002
Date Received06/14/2017
Decision Date08/07/2017
Product Code NIP 
Advisory Committee Cardiovascular
Clinical TrialsNCT01319812
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the final PMA PAS Protocol Administrative Addendum (dated June 6, 2017) containing the PAS long-term data analysis plan and for extending the Post-Approval Study (PAS) reporting frequency from 6 months to 12 months.
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