PMA P030053S035
- Device
- MENTOR MEMORYGEL BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S035
- Product code
- FTR
- Decision date
- 2016-07-05
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Use of previously approved Semi-Automated Primary Packaging Equipment SPPS following relocation from the Main Assembly Controlled Manufacturing Environment CME room to the Primary Packaging CME Room at the Mentor Irving, Texas facility.
Current openFDA PMA Record#
- Device
- MENTOR MEMORYGEL BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S035
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2016-07-05
- Decision code
- OK30
- Date received
- 2016-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of previously approved Semi-Automated Primary Packaging Equipment SPPS following relocation from the Main Assembly Controlled Manufacturing Environment CME room to the Primary Packaging CME Room at the Mentor Irving, Texas facility.