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 | QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | SUB-Q, INC. 1062-D CALLE NEGOCIO SAN CLEMENTE, CA 92673 |
PMA Number | P010049 |
Supplement Number | S002 |
Date Received | 04/22/2002 |
Decision Date | 06/13/2002 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENDING THE SHELF LIFE OF THE APPROVED QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM FROM 6 TO 24 MONTHS. |
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