# K082387: Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic Floor Repair System

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems
- Decided: Dec 4, 2008 after 107 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: 11 generations back to K931386 (1993). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051485: Ams Pelvic Floor Repair System, American Medical Systems, Inc. (2005) Summary page 1.

## Indications for use
AMS Pelvic Floor 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 for the treatment of incontinence, 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/K082387
Methodology: https://510kreport.com/methodology