# K090713: Elevate Prolapse Repair System with PC Coated Intepro Lite- Apical and Posterior Prolapse Repair System, Anterior and AP

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Apr 2, 2009 after 15 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Elevate Prolapse Repair System with IntePro Lite: named in the summary without a submission number

## Most influential descendants
- K111118: Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System with Intepro Lite (2011), 0 descendants of its own

## Indications for use
The AMS Elevate Prolapse Repair 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/K090713
Methodology: https://510kreport.com/methodology