- Device
- Mentor MemoryShape Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S049
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2023-08-08
- Decision code
- OK30
- Date received
- 2023-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new vulcanizer, which is equipment used to adhere the patch against the back of the implant shell by applying pressure during the patching and vulcanizing process.