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FDA 510(k) Application Details - K153088
Device Classification Name
More FDA Info for this Device
510(K) Number
K153088
Device Name
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
Applicant
BOSTON SCIENTIFIC CORPORATION
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact
ASHLEY SANTOS
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Regulation Number
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Classification Product Code
PCU
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More FDA Info for this Product Code
Date Received
10/26/2015
Decision Date
12/11/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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