- Device
- Saline-Filled and Spectrum Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S051
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2021-10-27
- Decision code
- APPR
- Date received
- 2021-05-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the patient and physician labeling including a boxed warning and a patient decision checklist.