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 | WALLSTENT TIPS ENDOPROSTHESIS |
Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P930031 |
Supplement Number | S005 |
Date Received | 04/22/1998 |
Decision Date | 11/30/1998 |
Product Code |
MIR |
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 the Unistep(TM) Plus 8 Fr delivery system. |
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