PMA P030053S042
- Device
- Mentor MemoryGel® Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S042
- Product code
- FTR
- Decision date
- 2017-05-24
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Conversion from the use of Biological Indicators to the use of Parametric Release for batch release of dry heat sterilized devices at the Mentor Texas facility.
Current openFDA PMA Record#
- Device
- Mentor MemoryGel® Silicone Gel-Filled Breast Implants
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S042
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2017-05-24
- Decision code
- OK30
- Date received
- 2017-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Conversion from the use of Biological Indicators to the use of Parametric Release for batch release of dry heat sterilized devices at the Mentor Texas facility.