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 CONTROL FEMORAL 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 | S009 |
Date Received | 10/02/2003 |
Decision Date | 12/23/2003 |
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 TO REDUCE THE MINIMUM REQUIRED ACCESS SITE DEPTH FROM 3 CENTIMETERS TO 2 CENTIMETERS IN THE INSTRUCTIONS FOR USE. |
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