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510(k) K182169

AdVance XP Male Sling by Boston Scientific Corporation — Product Code OTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2018
Date Received
August 10, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, For Stress Urinary Incontinence, Male
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

surgical treatment of male stress urinary incontinence post-prostatectomy

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