| |
| Trade Name | LIBERTE CORONARY STENT SYSTEM |
| Classification Name | stent, coronary |
| Generic Name | intravascular stent with delivery system |
| Applicant | BOSTON SCIENTIFIC CORP. |
| PMA Number | P040016 |
| Supplement Number | S023 |
| Date Received | 03/16/2007 |
| Decision Date | 04/04/2007 |
| 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 Modification to the proximal weld in-process acceptance criteria in the manufacture of the device. |