ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM

Stent, Superficial Femoral Artery

FDA Premarket Approval P160025

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.

Pre-market Approval Supplement Details

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.

DeviceASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
Classification NameStent, Superficial Femoral Artery
Generic NameStent, Superficial Femoral Artery
ApplicantBIOTRONIK, INC.
Date Received2016-07-22
Decision Date2017-03-23
Notice Date2017-03-29
PMAP160025
SupplementS
Product CodeNIP
Docket Number17M-1845
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

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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