AngioSculpt PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

FDA Premarket Approval P050018 S028

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

Approval for a material change at a supplier

DeviceAngioSculpt PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating
Generic NameCatheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
ApplicantSPECTRANETICS CORP.
Date Received2020-08-24
Decision Date2020-09-21
PMAP050018
SupplementS028
Product CodeNWX 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SPECTRANETICS CORP. 5055 Brandin Court fremont, CA 94538

Supplemental Filings

Supplement NumberDateSupplement Type
P050018Original Filing
S028 2020-08-24 30-day Notice
S027 2019-08-01 30-day Notice
S026
S025 2018-09-20 30-day Notice
S024 2017-03-24 30-day Notice
S023
S022 2016-06-08 Real-time Process
S021 2016-03-28 30-day Notice
S020
S019 2013-07-24 30-day Notice
S018 2012-11-30 Normal 180 Day Track
S017 2012-05-10 Normal 180 Day Track
S016 2011-11-16 30-day Notice
S015 2011-09-29 30-day Notice
S014 2011-04-13 30-day Notice
S013 2011-03-29 30-day Notice
S012 2010-12-02 Normal 180 Day Track No User Fee
S011 2010-10-12 30-day Notice
S010 2010-08-12 30-day Notice
S009
S008 2009-08-10 Real-time Process
S007 2009-05-20 Special (immediate Track)
S006 2009-05-18 135 Review Track For 30-day Notice
S005 2008-12-31 30-day Notice
S004 2008-03-12 Normal 180 Day Track No User Fee
S003 2007-05-30 Normal 180 Day Track No User Fee
S002 2007-04-04 Real-time Process
S001 2007-02-07 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00813132026875 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026851 P050018 000
00813132026844 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026813 P050018 000
00813132026806 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026936 P050018 000
00813132026929 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026899 P050018 000
00813132026882 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026851 P050018 000
00813132026844 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026813 P050018 000
00813132026806 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026936 P050018 000
00813132026929 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026882 P050018 000
00813132026899 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026905 P050018 000
00813132026912 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026899 P050018 000
00813132026882 P050018 000
00813132026929 P050018 000
00813132026936 P050018 000
00813132026943 P050018 000
00813132026790 P050018 000
00813132026806 P050018 000
00813132026813 P050018 000
00813132026820 P050018 000
00813132026837 P050018 000
00813132026844 P050018 000
00813132026851 P050018 000
00813132026868 P050018 000
00813132026875 P050018 000
00813132026868 P050018 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.