PMA P990075S010
- Device
- MENTOR SALINE-FILLED BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S010
- Product code
- FWM
- Decision date
- 2003-03-07
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- USE OF A LASER TO ENGRAVE THE MENTOR NAME, LOGO, DEVICE LOT NUMBER, AND DEVICE VOLUME ONTO THE PATCH ON THE SHELL OF THE SALINE FILLED BREAST IMPLANTS.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S010
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2003-03-07
- Decision code
- OK30
- Date received
- 2003-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF A LASER TO ENGRAVE THE MENTOR NAME, LOGO, DEVICE LOT NUMBER, AND DEVICE VOLUME ONTO THE PATCH ON THE SHELL OF THE SALINE FILLED BREAST IMPLANTS.