PMA
P990075: MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
FDA PMA · Prosthesis, breast, inflatable, internal, saline · Mentor Worldwide, LLC
Key facts
| PMA number | P990075 |
|---|---|
| Trade name | MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES |
| Generic name | Prosthesis, breast, inflatable, internal, saline |
| Applicant | Mentor Worldwide, LLC |
| Owner/operator | MENTOR Texas, LP |
| Product code | FWM |
| Approval date | May 10, 2000 |
| Docket number | 01M-0011 |
| Notice date | Jan 18, 2001 |
| Establishment registration | 1645337 |
| FEI number | 1000118360 |
At a glance
- 10–99 Supplements
- May 12, 2026 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- No Withdrawn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: