PMA
P980053: DURASPHERE INJECTABLE BULKING AGENT
FDA PMA · AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE · Carbon Medical Technologies, Inc.
Key facts
| PMA number | P980053 |
|---|---|
| Trade name | DURASPHERE INJECTABLE BULKING AGENT |
| Generic name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Applicant | Carbon Medical Technologies, Inc. |
| Owner/operator | Carbon Medical Technologies, Inc. |
| Product code | LNM |
| Approval date | Sep 13, 1999 |
| Docket number | 99M-4278 |
| Notice date | Oct 15, 1999 |
| Establishment registration | 2134494 |
| FEI number | 3002619738 |
At a glance
- 10–99 Supplements
- Mar 13, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: