PMA supplement
P020056 S003: NATRELLE SILICONE-FILLED BREAST IMPLANT
FDA PMA supplement · Normal 180 Day Track No User Fee · Allergan
Key facts
| Original PMA | P020056 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | NATRELLE SILICONE-FILLED BREAST IMPLANT |
| Generic name | Prosthesis, breast, noninflatable, internal, silicone gel-filled |
| Applicant | Allergan |
| Product code | FTR |
| Received date | Feb 26, 2007 |
| Decision date | May 17, 2007 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: