| |
| Trade Name | PERCLOSE PROGLIDE SUTURE MEDIATED SYSTEM/PERCLOSE A T 6F SUTURE MEDIATED CLOSURE SYSTEM |
| Classification Name | device, hemostasis, vascular |
| Applicant | ABBOTT VASCULAR INC. |
| PMA Number | P960043 |
| Supplement Number | S067 |
| Date Received | 09/22/2009 |
| Decision Date | 10/21/2009 |
| 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 to a component of the sheath transitioning equipment. |