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 | VASOSEAL ES DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | St. Jude Medical, Inc. 177 E.COUNTY RD. B EAST ST PAUL, MN 55117 |
PMA Number | P920004 |
Supplement Number | S008 |
Date Received | 11/13/1997 |
Decision Date | 12/11/1998 |
Withdrawal Date
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12/06/2013 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval to market a modified version of the VasoSeal(R) Vascular Hemostasis Device. The device, as modified, will be marketed under the trade name VasoSeal(R) Extra Security (ES) Device and is indicated for reducing time to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography or interventional procedures. |
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