PMA
P990074: NATRELLE SALINE BREAST IMPLANTS
FDA PMA · Prosthesis, breast, inflatable, internal, saline · Allergan
Key facts
| PMA number | P990074 |
|---|---|
| Trade name | NATRELLE SALINE BREAST IMPLANTS |
| Generic name | Prosthesis, breast, inflatable, internal, saline |
| Applicant | Allergan |
| Owner/operator | AbbVie, Inc. |
| Product code | FWM |
| Approval date | May 10, 2000 |
| Docket number | 01M-0012 |
| Notice date | Jan 18, 2001 |
| Establishment registration | 2011068 |
| FEI number | 2011068 |
At a glance
- 10–99 Supplements
- Dec 16, 2024 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- No Withdrawn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: