| |
| Trade Name | ANGIO-SEAL VASULAR CLOSURE DEVICE |
| Classification Name | device, hemostasis, vascular |
| Generic Name | vascular hemostasis device |
| Applicant | ST. JUDE MEDICAL, INC. |
| PMA Number | P930038 |
| Supplement Number | S058 |
| Date Received | 04/15/2009 |
| Decision Date | 05/07/2009 |
| Product Code | |
| Advisory Committee |
Cardiovascular |
| Supplement Type | 30-day notice |
| Supplement Reason | process change: manufacturing |
| Expedited Review Granted? | No |
| Combination Product |
No
|
Approval Order Statement Change from a manual to an automated process for the evolution assembly. |