PMA P990075S053
- Device
- Saline-Filled and Spectrum Breast Implants
- Applicant
- Mentor Worldwide, LLC
- Product code
- FWM
- Decision date
- 2023-08-23
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval of the implementation of the Laser Marking System 04 for the SPECTRUM® Breast Implants.
Current openFDA PMA Record#
- Device
- Saline-Filled and Spectrum Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S053
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2023-08-23
- Decision code
- APPR
- Date received
- 2021-12-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of the implementation of the Laser Marking System 04 for the SPECTRUM® Breast Implants.