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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
Definition Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.
Product CodePAJ
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Pain 1 1
Itching Sensation 1 1
Pain 1 1

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