§878.3300. Surgical mesh. — Inbound Citations
21 C.F.R. § 878.3300
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 878.3300 as a whole
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(a) Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).