PMA P030053S052
- Device
- MemoryGel Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S052
- Product code
- FTR
- Decision date
- 2019-07-12
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Reconfiguration of the MemoryGel® Silicone Gel-Filled Breast Implant shell assembly and laser marking process steps from a batch process to a single piece flow manufacturing line. The change is applicable to the steps after the shells have been manufactured but before they are filled with gel and cured. The batch to single piece flow manufacturing process change is specific to the smooth shell surface version of the implants and is not applicable to the textured shell implant versions.
Current openFDA PMA Record#
- Device
- MemoryGel Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S052
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2019-07-12
- Decision code
- OK30
- Date received
- 2019-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reconfiguration of the MemoryGel® Silicone Gel-Filled Breast Implant shell assembly and laser marking process steps from a batch process to a single piece flow manufacturing line. The change is applicable to the steps after the shells have been manufactured but before they are filled with gel and cured. The batch to single piece flow manufacturing process change is specific to the smooth shell surface version of the implants and is not applicable to the textured shell implant versions.