# P990074: Natrelle Saline Breast Implants

- Pathway: PMA
- Applicant: Allergan
- Decided: May 10, 2000 after 176 days
- Product code: FWM (Prosthesis, Breast, Inflatable, Internal, Saline)
- Device class: 3
- Regulation: 21 CFR 878.3530
- Recalls of this device: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 6, 2019 · Class III · Z-0699-2020: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string
- Jul 24, 2019 · Class I · Z-2451-2019: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in pat
- Dec 14, 2005 · Not classified · Z-0337-06: Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. A
- Dec 14, 2005 · Not classified · Z-0336-06: Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. A
- May 5, 2005 · Not classified · Z-0851-05: Wrong size implant was mislabeled.

Source page: https://510kreport.com/device/P990074
Methodology: https://510kreport.com/methodology