PMA P060028S025
- Device
- Mentor MemoryShape Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S025
- Product code
- FTR
- Decision date
- 2017-09-01
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval of a product line extension to the currently marketed MemoryShape Silicone Gel-Filled Breast Implants product line involving additional breast implant options with volume and dimensional values that are bracketed within the currently approved ranges for the commercially available MemoryShape implants.
Current openFDA PMA Record#
- Device
- Mentor MemoryShape Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S025
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2017-09-01
- Decision code
- APPR
- Date received
- 2017-06-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of a product line extension to the currently marketed MemoryShape Silicone Gel-Filled Breast Implants product line involving additional breast implant options with volume and dimensional values that are bracketed within the currently approved ranges for the commercially available MemoryShape implants.