Submission Details
| 510(k) Number | K082387 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 19, 2008 |
| Decision Date | December 04, 2008 |
| Days to Decision | 107 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Special
K082387 - APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
(FDA 510(k) Clearance)
Dec 2008
Decision
107d
Days
Class 3
Risk
K082387 is an FDA 510(k) clearance for the APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM, a Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (Class III — Premarket Approval, product code OTP), submitted by American Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on December 4, 2008, 107 days after receiving the submission on August 19, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5980.
Device Classification
| Product Code | OTP — Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Device Class | Class III — Premarket Approval |
| CFR Regulation | 21 CFR 884.5980 |
| Definition | Tissue Reinforcement Of The Fibromuscular Layer Of The Pelvic Floor When Surgical Treatment Is Indicated; Procedures Include Anterior And Posterior Vaginal Wall Prolapse Repair And Vaginal Apical Or Uterine Prolapse Repair Performed Transvaginally |
Similar Devices — OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
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