PMA P030053S033
- Device
- MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S033
- Product code
- FTR
- Decision date
- 2016-04-15
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Update to the PROC000331 Packaging with Alloyd Heat Sealers and Tyvek Pouch to implement the use of Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices.
Current openFDA PMA Record#
- Device
- MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S033
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2016-04-15
- Decision code
- OK30
- Date received
- 2016-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the PROC000331 Packaging with Alloyd Heat Sealers and Tyvek Pouch to implement the use of Nilfisk GM80 CR Vacuum Cleaner around the heat sealers as a manufacturing aid to remove potential debris from equipment crevices.