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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
510(k) Number K122459
Models M0068317150, M0068317170
Device Name PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
Original Applicant
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough,  MA  01752
Original Contact michelle berry
Regulation Number878.3300
Classification Product Code
OTP  
Date Received08/13/2012
Decision Date 12/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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