# K112842: Ams Elevate PC

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Oct 25, 2011 after 26 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.
No later device cites it as a predicate yet.
0 of 1 device 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) AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite: named in the summary without a submission number
- (no number) AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite: named in the summary without a submission number

## Indications for use
The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement. The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

Source page: https://510kreport.com/device/K112842
Methodology: https://510kreport.com/methodology