Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB)

FDA Premarket Approval P160049 S011

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

Addition of sterilization chamber 4 in the los angeles, ca sterilization facility

DeviceStellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB)
Generic NameDrug-eluting Peripheral Transluminal Angioplasty Catheter
ApplicantThe Spectranetics Corp.
Date Received2021-01-21
Decision Date2021-02-19
PMAP160049
SupplementS011
Product CodeONU 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address The Spectranetics Corp. 6531 Dumbarton Circle fremont, CA 94555

Supplemental Filings

Supplement NumberDateSupplement Type
P160049Original Filing
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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