Vaginal Mesh FDA Approval
how vaginal meshes passed the FDA 51l0(k) pre-market notifica- tion process*: an example *(the one the Institute of Medicine described as an "(unreliable] pre-market screening of... safety and effectiveness")" between 1985-1995 Trelex Natural Mesh these products are cleared for a variety of uses. however, none are designed as vaginal meshes or cleared by the FDA for that use. Gore-Tex Soft Tissue Patch Supple Peri-Guard Mersilene Mesh Marlex Mesh in the 510(k) process, a new product must only be "substantially equivalent," or similar, to previously-approved "predicate" devices. no fur- ther testing is deemed necessary.? these are the predicate devices for 510(k) clearance** Boston. Scientific ProteGen Mesh despite being marketed as a vaginal mesh, ProteGen is approved based on its similarity to the products9 mentioned above. 1996 predicate device for 510(k) clearance** Tension-Free Vaginal Tape (TVT) Johnson-Johnson 1998 based on its similarity to Boston's ProteGen Boston Scientific voluntarily recalls 20,000 ProteGen Mesh products due to injuries? Boston. Scientific 1999: recall ProteGen Mesh "predicate device for" no known FDA investigation into vaginal mesh safety is conducted after the ProteGen recall? Sparc Sling AMS I.V.S.Tuneller System 510(k) clearance** 2001 COVIDIEN based on their similarity to J&J's TVT
Vaginal Mesh FDA Approval
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