PMA P030053S093
- Device
- MemoryGel™ Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S093
- Product code
- FTR
- Decision date
- 2026-10-23
- Classification
- General, Plastic Surgery
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- the addition of small size packaging tooling on the existing packaging equipment
Current openFDA PMA Record#
- Device
- MemoryGel™ Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S093
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2026-10-23
- Decision code
- OK30
- Date received
- 2026-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of small size packaging tooling on the existing packaging equipment