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 | GATED SUTURE TRIMMER ACCESSORY |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S056 |
Date Received | 08/05/2004 |
Decision Date | 09/10/2004 |
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 MODIFICATIONS TO THE GATED SUTURE TRIMMER ACCESSORY, SPECIFICALLY, OVERMOLDING THE TIP-SHEATH PROFILE AND INCREASING THE DIAMETER OF THE SHEATH TO MATCH THE NEW TIP DIAMETERS. |
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