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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBiotronik AG
Ackerstrasse 6
Bülach 8180
PMA NumberP160025
Date Received07/22/2016
Decision Date03/23/2017
Product Code NIP 
Docket Number 17M-1845
Notice Date 03/29/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT01319812
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Astron Pulsar Stent System and Pulsar-18 Stent System. These devices are indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3.0 to 6.0mm and total lesion lengths up to 190mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002  S001 S006 S007 S015 S012 S013 S010 S011 S017 S005 
S003 S004 S008 S024 S020 S018 S019 S025 S009 S022 S023 S014 
S016 
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