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 fact balloon coronary dilatation catheter marketed under trade name fact balloon coronary dilatation catheter
| Device | ORACLE(TM) CORONARY BALLOON DILATATION CATHETER |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ABBOTT VASCULAR DEVICES |
| Date Received | 1995-03-30 |
| Decision Date | 1995-10-03 |
| PMA | P910031 |
| Supplement | S002 |
| 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 |