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 VENOUS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM |
Generic Name | Stent, central venous |
Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P980033 |
Supplement Number | S025 |
Date Received | 09/28/2012 |
Decision Date | 10/24/2012 |
Product Code |
QKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE AERATION CYCLE TIME FOR AN ETHYLENE OXIDE STERILIZATION CYCLE. |
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