PMA P990075S049
- Device
- Saline-Filled and Spectrum Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S049
- Product code
- FWM
- Decision date
- 2020-12-01
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- changes to manufacturing equipment for production of Mentor Saline-filled and Spectrum Breast Implants
Current openFDA PMA Record#
- Device
- Saline-Filled and Spectrum Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S049
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2020-12-01
- Decision code
- OK30
- Date received
- 2020-10-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to manufacturing equipment for production of Mentor Saline-filled and Spectrum Breast Implants