Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | X-SITE SUTURE-MEDIATED CLOSURE DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | St. Jude Medical, Inc. 6500 WEDGWOOD RD. MAPLE GROVE, MN 55311 |
PMA Number | P020035 |
Supplement Number | S002 |
Date Received | 11/30/2005 |
Decision Date | 03/03/2006 |
Withdrawal Date
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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 VARIOUS LABELING CHANGES AND ERGONOMIC CHANGES TO THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME X-SITE SUTURE-MEDIATED CLOSURE DEVICE AND IS INDICATED FOR ??THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURES USING SHEATHS LESS THAN OR EQUAL TO 6 FR. THE X-SITE SUTURE-MEDIATED CLOSURE DEVICE IS INTENDED TO REDUCE THE TIME TO H0MOSTASIS, TIME TO AMBULATION (100 FEET), AND TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS, INCLUDING THOSE RECEIVING GLYCOPROTEIN IIB/IIIA INHIBITORS.? |
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