MENTOR MEMORYSHAPE BREAST IMPLANTS
FDA premarket approval P060028/S014 · decided 2016-02-05
Approval details
- PMA number
- P060028
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MENTOR MEMORYSHAPE BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2015-09-30
- Decision date
- 2016-02-05
- Days to decision
- 128 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- Approval for 1) change 100291296: Update packaging processes with Alloyd Heat Sealers and Tyvek Pouch to implement the use of the Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices; and 2) change 100248737: minor layout modifications to the gel fill area were made to increase operational efficiency.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (K242963) | Mentor Worldwide, LLC | 2025-04-24 |
| MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K243271) | Mentor Worldwide, LLC | 2025-01-13 |
| Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (K243836) | Mentor Worldwide, LLC | 2025-01-12 |
| MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K241552) | Mentor Worldwide, LLC | 2024-09-06 |
| MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (K241918) | Mentor Worldwide, LLC | 2024-08-02 |
| CPX 4 Breast Tissue Expander with Smooth Surface (K182335) | Mentor Worldwide, LLC | 2018-09-25 |
| ARTOURA Breast Tissue Expanders with Smooth Surface (K161176) | Mentor Worldwide, LLC | 2016-05-23 |
| CPX 4 Breast Tissue Expander (K152496) | Mentor Worldwide, LLC | 2016-02-19 |