PMA
P020056: NATRELLE SILICONE-FILLED BREAST IMPLANTS
FDA PMA · Prosthesis, breast, noninflatable, internal, silicone gel-filled · Allergan
Key facts
| PMA number | P020056 |
|---|---|
| Trade name | NATRELLE SILICONE-FILLED BREAST IMPLANTS |
| Generic name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Applicant | Allergan |
| Owner/operator | AbbVie, Inc. |
| Product code | FTR |
| Approval date | Nov 17, 2006 |
| Docket number | 06M-0490 |
| Notice date | Nov 17, 2006 |
| Establishment registration | 2011068 |
| FEI number | 2011068 |
At a glance
- 10–99 Supplements
- Sep 29, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1,000+ 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: