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 | VASCULAR SOLUTIONS DUETT SEALING DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | Vascular Solutions, Inc. 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 |
PMA Number | P990037 |
Supplement Number | S026 |
Date Received | 07/11/2008 |
Decision Date | 08/07/2008 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE QUALITY CONTROL DEVICE USED TO MONITOR THE STERILIZATION PROCESS, AND A CHANGE IN THE MATERIALS USED IN ONE ACCESSORY COMPONENT (SMALL BORE APPLICATOR TIP). |
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