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510(k) K081275

BOSTON SCIENTIFIC SURGICAL MESH by Boston Scientific Corp — Product Code PAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2008
Date Received
May 5, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Device Class
Class II
Regulation Number
878.3300
Review Panel
GU
Submission Type

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

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