Mentor Saline-Filled and SPECTRUM Breast Implants
FDA premarket approval P990075/S048 · decided 2020-10-30
Approval details
- PMA number
- P990075
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Mentor Saline-Filled and SPECTRUM Breast Implants
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2020-09-30
- Decision date
- 2020-10-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- Change in manufacturing equipment and supplier location for molding components of the Dome Pack accessories that are provided with the Spectrum® Saline-Filled Breast Implants.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |