PMA P990075S023
- Device
- MENTOR SALINE-FILLED BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S023
- Product code
- FWM
- Decision date
- 2013-05-15
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- ADD AN ADDITIONAL SUPPLIER OF THE DIAPHRAGM VALVE COMPONENT USED IN THE MANUFACTURE OF THE MENTOR SALINE-FILLED BREAST IMPLANTS.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S023
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2013-05-15
- Decision code
- OK30
- Date received
- 2013-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN ADDITIONAL SUPPLIER OF THE DIAPHRAGM VALVE COMPONENT USED IN THE MANUFACTURE OF THE MENTOR SALINE-FILLED BREAST IMPLANTS.