# P030053: Memorygel Silicone Gel -Filled Breast Implants

- Pathway: PMA
- Applicant: Mentor Corp.
- Decided: Nov 17, 2006 after 1,071 days
- Product code: FTR (Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled)
- Device class: 3
- Regulation: 21 CFR 878.3540
- Recalls of this device: 1 (0 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.
0 of 1 device in its family (counting itself) have 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
- Jul 1, 2016 · Class II · Z-2326-2016: The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.

Source page: https://510kreport.com/device/P030053
Methodology: https://510kreport.com/methodology