Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device

Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Advantage/advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (curved & Halo), Obtryx Ii Delivery Device (curved & Halo), Solyx Sis Delivery Device.

Pre-market Notification Details

Device IDK172565
510k NumberK172565
Device Name:Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
ClassificationInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
Applicant Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
ContactAnand Patel
CorrespondentAnand Patel
Boston Scientific Corporation 100 Boston Scientific Way Marlborough,  MA  01752
Product CodePWJ  
CFR Regulation Number884.4910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-25
Decision Date2017-12-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.