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 | ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM |
Generic Name | Device, hemostasis, vascular |
Applicant | TERUMO MEDICAL CORPORATION 950 ELKTON BLVD. ELKTON, MD 21921 |
PMA Number | P930038 |
Supplement Number | S035 |
Date Received | 11/20/2002 |
Decision Date | 12/20/2002 |
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 INSERTION SHEATH (ADDITION OF PUNCTURE HOLES), GUIDEWIRE (INCREASE GUIDEWIRE SIZE FOR THE 6FR. DEVICE), PUNCTURE LOCATOR (MOVE LOCATOR HOLES, LABEL LOCATION (MOVE TO OUTSIDE OF PACKAGE) AND THE INSTRUCTIONS FOR USE (REVISE LABELING TO INCLUDE NEW INSTRUCTIONS RELATED TO THESE DESIGN CHANGES). |
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