| |
| Trade Name | PAS CHAMPION HP PTCA CATHETER |
| Classification Name | catheters, transluminal coronary angioplasty, percutaneous |
| Generic Name | ptca catheter |
| Regulation Number | 870.5100 |
| Applicant | PROGRESSIVE ANGIOPLASTY SYSTEMS, INC. |
| PMA Number | P930012 |
| Supplement Number | S005 |
| Date Received | 08/01/1996 |
| Decision Date | 01/29/1997 |
| Product Code | |
| Advisory Committee |
Cardiovascular |
| Supplement Type | normal 180 day track |
| Supplement Reason | change design/components/specifications - other |
| Expedited Review Granted? | No |
| Combination Product |
No
|
Approval Order Statement 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. |