PMA P060028S020
- Device
- Mentor MemoryShape Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S020
- Product code
- FTR
- Decision date
- 2017-04-04
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Addition of Vinatoru equipment for seal strength testing of packaging components that are used for Mentor Saline-Filled and SPECTRUM® Breast Implants, MemoryGel® Silicone Gel-Filled Breast Implants and MemoryShapeTM Breast Implants and their accessories.
Current openFDA PMA Record#
- Device
- Mentor MemoryShape Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P060028
- Supplement
- S020
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2017-04-04
- Decision code
- OK30
- Date received
- 2017-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of Vinatoru equipment for seal strength testing of packaging components that are used for Mentor Saline-Filled and SPECTRUM® Breast Implants, MemoryGel® Silicone Gel-Filled Breast Implants and MemoryShapeTM Breast Implants and their accessories.