Saline-Filled and Spectrum Breast Implants
FDA premarket approval P990075/S051 · decided 2021-10-27
Approval details
- PMA number
- P990075
- Supplement
- S051
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Saline-Filled and Spectrum Breast Implants
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2021-05-25
- Decision date
- 2021-10-27
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.
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510(k) clearances by this applicant
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|---|---|---|
| MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (K242963) | Mentor Worldwide, LLC | 2025-04-24 |
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| 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 |