PMA P030053S034
- Device
- MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S034
- Product code
- FTR
- Decision date
- 2016-06-22
- Classification
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Approval order statement
- Implementation of a multi-booth spray system for shell manufacture.
Current openFDA PMA Record#
- Device
- MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
- Applicant
- Mentor Corp.
- PMA number
- P030053
- Supplement
- S034
- Product code
- FTR
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Decision date
- 2016-06-22
- Decision code
- OK30
- Date received
- 2016-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a multi-booth spray system for shell manufacture.