# K082730: Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate Apical and Posterior Prolapse

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Nov 26, 2008 after 69 days
- Product code: OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K931386 (1993). 40 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080185: Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP Prolapse Repair System, American Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K121612: Elevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification (2012), 0 descendants of its own

## Indications for use
The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

Source page: https://510kreport.com/device/K082730
Methodology: https://510kreport.com/methodology