MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

FDA Premarket Approval P910031 S023

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 the merlin ptca catheter (otw) and nc merlin ptca catheter (otw). The merlin ptca catheter (otw) is indicated for use in balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The nc merlin ptca catheter (otw) is indicated for use in balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, and for the post-delivery expansion of balloon expandable stents.

DeviceMERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantABBOTT VASCULAR DEVICES
Date Received2004-11-16
Decision Date2006-02-16
PMAP910031
SupplementS023
Product CodeLOX 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR DEVICES 400 Saginaw Dr. redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P910031Original Filing
S026 2009-07-29 30-day Notice
S025
S024 2007-05-04 Normal 180 Day Track No User Fee
S023 2004-11-16 Normal 180 Day Track
S022 2004-11-01 Normal 180 Day Track
S021 2001-12-06 Normal 180 Day Track
S020
S019 1998-06-15 Normal 180 Day Track
S018
S017 1997-10-14 Real-time Process
S016 1997-05-22 Real-time Process
S015 1997-03-28 Normal 180 Day Track
S014
S013
S012 1996-09-30 Normal 180 Day Track
S011 1996-08-26 Normal 180 Day Track
S010 1996-07-23 Normal 180 Day Track
S009 1996-05-15 Normal 180 Day Track
S008 1996-02-09 Normal 180 Day Track
S007 1996-01-26 Normal 180 Day Track
S006 1995-11-03 Normal 180 Day Track
S005 1995-09-07 Normal 180 Day Track
S004 1995-08-18 Normal 180 Day Track
S003 1995-06-02 Normal 180 Day Track
S002 1995-03-30 Normal 180 Day Track
S001 1994-11-21 Normal 180 Day Track

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