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 | EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
PMA Number | P090003 |
Supplement Number | S013 |
Date Received | 07/05/2012 |
Decision Date | 08/03/2012 |
Product Code |
NIO |
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 THE 40C ETHYLENE OXIDE STERILIZATION CYCLE. |
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