STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

Drug-eluting Peripheral Transluminal Angioplasty Catheter

FDA Premarket Approval P160049

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 of the stellarex 0. 035 otw drug-coated angioplasty balloon. This device is indicated for percutaneous transluminal angioplasty (pta), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.

DeviceSTELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
Classification NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantThe Spectranetics Corp.
Date Received2016-11-02
Decision Date2017-07-26
Notice Date2017-07-28
PMAP160049
SupplementS
Product CodeONU
Docket Number17M-4498
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product Yes
Applicant Address The Spectranetics Corp. 6531 Dumbarton Circle fremont, CA 94555
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P160049Original Filing
S019 2022-06-14 30-day Notice
S018 2022-04-01 Normal 180 Day Track No User Fee
S017 2022-03-17 30-day Notice
S016
S015 2021-09-29 Panel Track
S014
S013 2021-09-17 Normal 180 Day Track No User Fee
S012 2021-05-07 Normal 180 Day Track No User Fee
S011 2021-01-21 30-day Notice
S010
S009
S008 2020-01-15 30-day Notice
S007 2019-09-03 Special (immediate Track)
S006 2019-05-13 30-day Notice
S005 2019-04-08 30-day Notice
S004
S003 2018-10-01 Normal 180 Day Track No User Fee
S002 2018-01-22 Real-time Process
S001 2017-09-01 Real-time Process

NIH GUDID Devices

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