PMA P990075S045
- Device
- Spectrum Saline-Filled Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S045
- Product code
- FWM
- Decision date
- 2019-07-24
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Change in manufacturing process for the Plug Cap for the Spectrum Saline-filled Breast Implants from a transfer molding process to a liquid injection molding process.
Current openFDA PMA Record#
- Device
- Spectrum Saline-Filled Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S045
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2019-07-24
- Decision code
- OK30
- Date received
- 2019-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in manufacturing process for the Plug Cap for the Spectrum Saline-filled Breast Implants from a transfer molding process to a liquid injection molding process.