PMA
P170023: Bulkamid Urethral Bulking System
FDA PMA · AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE · Boston Scientific Corporation
Key facts
| PMA number | P170023 |
|---|---|
| Trade name | Bulkamid Urethral Bulking System |
| Generic name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Applicant | Boston Scientific Corporation |
| Owner/operator | Boston Scientific Corporation |
| Product code | LNM |
| Approval date | Jan 28, 2020 |
| Docket number | 20M-0495 |
| Notice date | Jan 30, 2020 |
| Establishment registration | 3002968685 |
At a glance
- 10–99 Supplements
- Jul 1, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: