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 pas champion(tm) hp (high pressure) ptca catheter with the following balloon sizes:3. 0 mm, 3. 5 mm, 4. 0 mm diameters with 15 mm and 20 mm lengths. This 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 | PAS CHAMPION HP PTCA CATHETER |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | PROGRESSIVE ANGIOPLASTY SYSTEMS, INC. |
| Date Received | 1996-08-01 |
| Decision Date | 1997-01-29 |
| PMA | P930012 |
| Supplement | S005 |
| 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 | 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 |