| |
| Trade Name | SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE |
| Classification Name | catheters, transluminal coronary angioplasty, percutaneous |
| Generic Name | coronary balloon dilatation catheter |
| Applicant | ADVANCED CATHETER SYSTEMS |
| PMA Number | P810046 |
| Supplement Number | S036 |
| Date Received | 07/31/1987 |
| Decision Date | 10/06/1987 |
| Product Code | |
| Advisory Committee |
Cardiovascular |
| Supplement Type | normal 180 day track |
| Supplement Reason | change design/components/specifications - other |
| Expedited Review Granted? | No |