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 oracle megasonics five-64(tm) ptca catheter. The device, as modified, will be marketed under the trade name oracle megasonics five-64(tm) ptca catheter and is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts for the purpose of improving myocardial perfusion. The catheter is further indicated for use following balloon dilatation as an adjunct to conventional angiographic procedures to provide: 1) an image of the vessel lumen and wall structures and 2) dimensional measurements from the image.
| Device | ORACLE MEGASONICS FIVE-64 PTCA CATHETER |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ABBOTT VASCULAR DEVICES |
| Date Received | 1997-03-28 |
| Decision Date | 1998-05-01 |
| PMA | P910031 |
| Supplement | S015 |
| 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 |