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: 1)an additional manufacturing site (13900 alton parkway, suite 122, irvine, ca, 92718); 2) an alternate sterilization site (griffith micro science, 4900 gifford ave. , los angeles, ca, 90058); and 3) an increase in the shelf life from one to two years
| Device | CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ABBOTT VASCULAR DEVICES |
| Date Received | 1996-01-26 |
| Decision Date | 1996-05-30 |
| PMA | P910031 |
| Supplement | S007 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |