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. |
|
Device | QUICKSEAL II 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 | S004 |
Date Received | 11/29/2002 |
Decision Date | 02/10/2003 |
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 TO MODIFY THE DESIGN OF THE DEPTH MARKET COMPONENT AND ELONGATE THE EXISTING CAVITY IN THE TRAY TO ACCOMMODATE THE DEPTH MARKET MODIFICATION. |
|
|