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 (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P940019 |
Supplement Number | S018 |
Date Received | 12/20/2004 |
Decision Date | 01/14/2005 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES IN THE MANUFACTURING PROCESS: 1) INTRODUCTION OF A TIP TUG TEST ON-LINE AT THE FINAL INSPECTION STEP, 2) INTRODUCTION OF AN AUTOMATED AUTO-FEED SYSTEM TO THE EXISTING SWAGER UNIT, AND 3) INTRODUCTION OF SEMI-AUTOMATED MANUFACTURING SIDE ARM CONNECTORS AS AN ALTERNATIVE TO THE MANUAL MANUFACTURING PROCESS. |
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