PMA P990075S056
- Device
- Mentor Spectrum Breast Implants, Mentor Saline-Filled Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S056
- Product code
- FWM
- Decision date
- 2023-05-24
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Implementation of a new rubber processing mill
Current openFDA PMA Record#
- Device
- Mentor Spectrum Breast Implants, Mentor Saline-Filled Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S056
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2023-05-24
- Decision code
- OK30
- Date received
- 2023-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new rubber processing mill