AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM— 510(k) K080185

Clearance details

Applicant

American Medical Systems, Inc.

Product code

Code OTP

Device class

Class 3

Regulation

21 CFR 884.5980

Advisory panel

Obstetrics/Gynecology

Date received

2008-01-25

Decision date

2008-04-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Minnetonka, MN, US

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• K103426 — LITE PELVIC FLOOR REPAIR KITS2011-09-14
• K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM2011-09-08

• K132655 — RETROARC RETROPUBIC SLING SYSTEM2013-11-20
• K100807 — MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 7201912010-06-07
• K092735 — GREENLIGHT XPS LASER SYSTEM2009-11-09
• K090934 — PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM2009-06-02
• K090663 — AMS SPECTRA CONCEALABLE PENILE PROSTHESIS2009-04-09

Injury

1,061

Total

1,061

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →