Saline and SPECTRUM Saline-Filled Breast Implants
FDA premarket approval P990075/S063 · decided 2025-08-12
Approval details
- PMA number
- P990075
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Saline and SPECTRUM Saline-Filled Breast Implants
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2025-04-30
- Decision date
- 2025-08-12
- Days to decision
- 104 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- Requalification of dry heat sterilization parameters/methods was sufficient.
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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 |