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.
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.
| Device | JOMED JOCATH GLADIATOR PTCA CATHETER (OTW) |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ABBOTT VASCULAR DEVICES |
| Date Received | 2001-12-06 |
| Decision Date | 2003-08-01 |
| PMA | P910031 |
| Supplement | S021 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR DEVICES 400 Saginaw Dr. redwood City, CA 94063 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910031 | Original 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 |