PMA P990075S032
- Device
- MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S032
- Product code
- FWM
- Decision date
- 2015-04-29
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- CHANGE TO CONVERT AN EXISTING IN-PROCESS COMPONENT STORAGE AREA INTO A CLEAN MANUFACTURING ENVIRONMENT (CME) FOR THE MANUFACTURE OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED, MEMORYSHAPE, AND SALINE-FILLED AND SPECTRUM BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S032
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2015-04-29
- Decision code
- OK30
- Date received
- 2015-04-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO CONVERT AN EXISTING IN-PROCESS COMPONENT STORAGE AREA INTO A CLEAN MANUFACTURING ENVIRONMENT (CME) FOR THE MANUFACTURE OF MEMORYSHAPE, AND MEMORYGEL SILICONE GEL-FILLED, MEMORYSHAPE, AND SALINE-FILLED AND SPECTRUM BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.