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 | GORE VIATORR TIPS ENDOPROSTHESIS |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | W. L. GORE & ASSOCIATES, INC. 32360 N NORTH VALLEY PARKWAY PHOENIX, AZ 85085 |
PMA Number | P040027 |
Supplement Number | S010 |
Date Received | 01/22/2008 |
Decision Date | 05/29/2008 |
Product Code |
MIR |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1) A CHANGE IN THE TYPE OF COOLING GAS; 2) A CHANGE IN THE APPLICATION OF THE COOLANT; AND 3) THE ADDITION OF A TEMPERATURE CONTROLLER. |
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