PMA P060028S027
- Device
- Mentor MemoryShape Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S027
- Product code
- FTR
- Decision date
- 2017-12-06
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval for changes to the labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
Current openFDA PMA Record#
- Device
- Mentor MemoryShape Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S027
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2017-12-06
- Decision code
- APPR
- Date received
- 2017-11-06
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).