FDA device listing
Avaulta Plus Support System,Avaulta Solo Support System,Avaulta Support System
FDA device listing 1429722011 · C. R. Bard, Inc.
Key facts
| Proprietary names | Avaulta Plus Support System,Avaulta Solo Support System,Avaulta Support System |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Premarket submissions | K082571 |
| Product codes | OTP, PAI |
| Device names | OTP - Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, PAI - Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Device class | Class III |
| Classification regulations (21 CFR) | 884.5980 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | C.R. BARD, INC. |
| Establishment registrations | 1018233 |
| FEI numbers | 1018233 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database