PMA P030053S039
- Device
- MemoryGel Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S039
- Product code
- FTR
- Decision date
- 2017-04-10
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Addition of a new semi-automated secondary packaging line which will include electronic label and component verification equipment.
Current openFDA PMA Record#
- Device
- MemoryGel Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S039
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2017-04-10
- Decision code
- OK30
- Date received
- 2017-03-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new semi-automated secondary packaging line which will include electronic label and component verification equipment.