ANGIOSCULPT(R) PTCA SCORING BALLOON CATHETER

Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring

FDA Premarket Approval P050018 S022

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 non-patient contacting material change for a component of the angiosculpt ptca scoring balloon catheter.

DeviceANGIOSCULPT(R) PTCA SCORING BALLOON CATHETER
Classification NameCatheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
Generic NameCatheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
ApplicantSPECTRANETICS CORP.
Date Received2016-06-08
Decision Date2016-09-06
PMAP050018
SupplementS022
Product CodeNWX
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address SPECTRANETICS CORP. 5055 Brandin Court fremont, CA 94538

Supplemental Filings

Supplement NumberDateSupplement Type
P050018Original Filing
S031 2021-06-28 30-day Notice
S030
S029
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
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00813132026813 P050018 026
00813132026806 P050018 026
00813132026943 P050018 026

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