MENTOR MEMORYSHAPE BREAST IMPLANTS
FDA premarket approval P060028/S005 · decided 2015-03-02
Approval details
- PMA number
- P060028
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MENTOR MEMORYSHAPE BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2014-12-22
- Decision date
- 2015-03-02
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- APPROVAL FOR A CHANGE TO A LOW BLEED PATCH DESIGN FOR MEMORYSHAPE BREAST IMPLANTS.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |