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 ARTERIAL CLOSURE SYSTEM WITH Q-FOAM |
Generic Name | Device, hemostasis, vascular |
Applicant | SUB-Q, INC. 1062-D CALLE NEGOCIO SAN CLEMENTE, CA 92673 |
PMA Number | P010049 |
Supplement Number | S001 |
Date Received | 04/08/2002 |
Decision Date | 09/16/2002 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN HEMOSTATIC MATERIAL FROM GELFOAM TO Q-FOAM. |
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