JOMED JOCATH GLADIATOR PTCA CATHETER (OTW)

FDA Premarket Approval P910031 S021

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 jomed jocath gladiator ptca catheter (otw). The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

DeviceJOMED JOCATH GLADIATOR PTCA CATHETER (OTW)
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantABBOTT VASCULAR DEVICES
Date Received2001-12-06
Decision Date2003-08-01
PMAP910031
SupplementS021
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.