PMA P030053S037
- Device
- MemoryGel Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S037
- Product code
- FTR
- Decision date
- 2017-04-13
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Approval of a product line extension to the currently marketed MemoryGel® Silicone Gel-Filled Breast Implants Smooth product line involving additional breast implant options with increased fill volume but within approved dimension and volume ranges.
Current openFDA PMA Record#
- Device
- MemoryGel Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S037
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2017-04-13
- Decision code
- APPR
- Date received
- 2017-02-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of a product line extension to the currently marketed MemoryGel® Silicone Gel-Filled Breast Implants Smooth product line involving additional breast implant options with increased fill volume but within approved dimension and volume ranges.