PMA
P040046: NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
FDA PMA · Prosthesis, breast, noninflatable, internal, silicone gel-filled · Allergan
Key facts
| PMA number | P040046 |
|---|---|
| Trade name | NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS |
| Generic name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Applicant | Allergan |
| Owner/operator | AbbVie, Inc. |
| Product code | FTR |
| Approval date | Feb 20, 2013 |
| Docket number | 13M-0255 |
| Notice date | Mar 13, 2013 |
| Establishment registration | 2011068 |
| FEI number | 2011068 |
At a glance
- 10–99 Supplements
- Jul 26, 2021 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: