Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter

FDA Premarket Approval P160049 S019

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.

Pre-market Approval Supplement Details

DeviceStellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantThe Spectranetics Corp.6531 Dumbarton Circlefremont, CA 94555 PMA NumberP160049 Supplement NumberS019 Date Received06/14/2022 Decision Date07/15/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-06-14
Decision Date2022-07-15
PMAP160049
SupplementS019
Product CodeONU 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressThe Spectranetics Corp.
6531 Dumbarton Circle
fremont, CA 94555 PMA NumberP160049 Supplement NumberS019 Date Received06/14/2022 Decision Date07/15/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
a Change In Supplier Of A Packaging Material

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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