PMA P990075S057
- Device
- Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S057
- Product code
- FWM
- Decision date
- 2023-06-02
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Change to the Thermoform mold for an increase in cavitation from 4 to 6 cavity molds.
Current openFDA PMA Record#
- Device
- Mentor Saline-Filled Brest Implants, Mentor SPECTRUM® Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S057
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2023-06-02
- Decision code
- OK30
- Date received
- 2023-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the Thermoform mold for an increase in cavitation from 4 to 6 cavity molds.