CATHSCANNER ORACLE MICRO PTCA CATHETER

FDA Premarket Approval P910031 S003

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 endosonics oracle focus ptca catheter, as modified will be marketed under the trade name endosonics oracle focus ptca catheter

DeviceCATHSCANNER ORACLE MICRO PTCA CATHETER
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantABBOTT VASCULAR DEVICES
Date Received1995-06-02
Decision Date1995-12-07
PMAP910031
SupplementS003
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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