MENTOR SALINE-FILLED BREAST IMPLANTS
FDA premarket approval P990075/S023 · decided 2013-05-15
Approval details
- PMA number
- P990075
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MENTOR SALINE-FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Mentor Worldwide, LLC
- Date received
- 2013-05-01
- Decision date
- 2013-05-15
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvin, CA
- Statement
- ADD AN ADDITIONAL SUPPLIER OF THE DIAPHRAGM VALVE COMPONENT USED IN THE MANUFACTURE OF THE MENTOR SALINE-FILLED BREAST IMPLANTS.
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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 |