PMA P990075S027
- Device
- MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S027
- Product code
- FWM
- Decision date
- 2014-10-29
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- CHANGE TO CONVERT THE MANUAL BARCODE MANUFACTURING PROCESS TO AN AUTOMATED PROCESS TO THE MANDREL USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
Current openFDA PMA Record#
- Device
- MENTOR SPECTRUM AND SALINE-FILLED BREAST IMPLANTS
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S027
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2014-10-29
- Decision code
- OK30
- Date received
- 2014-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO CONVERT THE MANUAL BARCODE MANUFACTURING PROCESS TO AN AUTOMATED PROCESS TO THE MANDREL USED IN THE PRODUCTION OF MEMORYSHAPE, MEMORYGEL SILICONE GEL-FILLED, SPECTRUM AND SALINE-FILLED BREAST IMPLANTS MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.