|
Device | X-PRESS TRIMMER - ACCESSORY TO THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | St. Jude Medical, Inc. 6500 WEDGWOOD RD. MAPLE GROVE, MN 55311 |
PMA Number | P020035 |
Supplement Number | S001 |
Date Received | 11/04/2003 |
Decision Date | 12/18/2003 |
Withdrawal Date
|
11/04/2010 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW ACCESSORY THAT INCORPORATES THE KNOT PUSHER AND SUTURE CUTTER ACCESSORIES INTO A SINGLE DEVICE. THIS NEWLY CREATED ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME X-PRESS TRIMMER, WHICH ALLOWS THE OPERATOR TO PUSH THE CLINCH KNOT AND CUT THE SUTURE BELOW THE SKIN LINE FOLLOWING THE USE OF THE X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM. |