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 addition of (1) quarter-size diameter balloons, including sizes of 2. 5 mm, 2. 75 mm, 3. 25 mm, 3. 75 mm, 4. 25 mm, and 4. 5 mm, and (2) a second radiopaque marker to all 20 mm long balloon catheters. The referenced devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
| Device | CHAMPION WRAP PTCA CATHETER |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | PROGRESSIVE ANGIOPLASTY SYSTEMS, INC. |
| Date Received | 1998-01-08 |
| Decision Date | 1998-02-23 |
| PMA | P930012 |
| Supplement | S009 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PROGRESSIVE ANGIOPLASTY SYSTEMS, INC. 1350 Willow Rd. Suite 201 menlo Park, CA 94025 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930012 | Original Filing | |
| S012 | 1998-07-24 | Normal 180 Day Track |
| S011 | 1998-08-03 | Real-time Process |
| S010 | 1998-05-08 | Real-time Process |
| S009 | 1998-01-08 | Real-time Process |
| S008 | 1997-08-19 | Normal 180 Day Track |
| S007 | ||
| S006 | 1997-03-06 | Normal 180 Day Track |
| S005 | 1996-08-01 | Normal 180 Day Track |
| S004 | 1996-06-27 | Normal 180 Day Track |
| S003 | 1995-11-13 | Normal 180 Day Track |
| S002 | 1995-10-04 | Normal 180 Day Track |
| S001 | 1995-10-04 | Normal 180 Day Track |