FDA device listing
Bulkamid Urethral Bulking System
FDA device listing 1712452773 · Boston Scientific Corporation
Key facts
| Proprietary names | Bulkamid Urethral Bulking System |
|---|---|
| Owner/operator | Boston Scientific Corporation |
| Owner/operator number | 9912058 |
| Premarket submissions | P170023 |
| Product codes | LNM |
| Device names | LNM - Agent, Bulking, Injectable For Gastro-Urology Use |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LNM |
| Review panels | Gastroenterology & Urology |
| Registered establishments | AXONICS, INC., Boston Scientific Corporation |
| Establishment registrations | 2124215, 3002968685 |
| FEI numbers | 2124215, 3002968685 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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