PMA P990075S060
- Device
- Mentor Saline-Filled and SPECTRUM® Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S060
- Product code
- FWM
- Decision date
- 2024-03-11
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Approval for packaging changes to primary packaging components
Current openFDA PMA Record#
- Device
- Mentor Saline-Filled and SPECTRUM® Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S060
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2024-03-11
- Decision code
- APPR
- Date received
- 2023-12-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for packaging changes to primary packaging components