# P060028: Mentor Memoryshape Breast Implants

- Pathway: PMA
- Applicant: Mentor Worldwide, LLC
- Decided: Jun 14, 2013 after 2,447 days
- Product code: FTR (Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled)
- Device class: 3
- Regulation: 21 CFR 878.3540
- Recalls of this device: none
- 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.

Source page: https://510kreport.com/device/P060028
Methodology: https://510kreport.com/methodology