PMA P990075S033
- Device
- MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S033
- Product code
- FWM
- Decision date
- 2015-07-01
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- CHANGES TO ADD A NEW CLEAN MANUFACTURING ENVIRONMENT (CME) ROOM FOR THE STORAGE OF DEVICE COMPONENT SHELLS. THE BREAST IMPLANTS ARE MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S033
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2015-07-01
- Decision code
- OK30
- Date received
- 2015-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO ADD A NEW CLEAN MANUFACTURING ENVIRONMENT (CME) ROOM FOR THE STORAGE OF DEVICE COMPONENT SHELLS. THE BREAST IMPLANTS ARE MANUFACTURED AT MENTOR'S IRVING, TEXAS FACILITY.