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 | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P020009 |
Supplement Number | S035 |
Date Received | 12/21/2006 |
Decision Date | 05/10/2007 |
Withdrawal Date
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12/06/2018 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE METHOD FOR LOADING DIE TEMPERATURE, HEAT TIME, AND PRODUCTION LINE SETTINGS FOR THE DISTAL HEAT SHRINK PROCESS USED IN MANUFACTURING OF THE DEVICES AT THE GALWAY, IRELAND MANUFACTURING SITE. |
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