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 | MAGIC WALLSTENT ENDOPROSTHESIS SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. TWO SCIMED PLACE MAPLE GROVE, MN |
PMA Number | P980009 |
Supplement Number | S012 |
Date Received | 02/03/2003 |
Decision Date | 02/26/2003 |
Withdrawal Date
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09/28/2007 |
Product Code |
MAF |
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 IN THE MANUFACTURING PROCESS TO TRANSFER SEVERAL PRODUCTION STEPS TO AN ALTERNATE SET OF PRODUCTION EQUIPMENT & RE-ORDERING THE MANUFACTURING PROCESS SEQUENCE AND ELIMINATING DUPLICATE INSPECTION CHECKS. |
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