PMA P060028S034
- Device
- MemoryShape Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S034
- Product code
- FTR
- Decision date
- 2019-11-19
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Qualification of new manufacturing equipment related to the removal of foreign debris from packaging used for MemoreShape Silicone Gel-Filled Breast Implants.
Current openFDA PMA Record#
- Device
- MemoryShape Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S034
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2019-11-19
- Decision code
- OK30
- Date received
- 2019-10-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of new manufacturing equipment related to the removal of foreign debris from packaging used for MemoreShape Silicone Gel-Filled Breast Implants.