PMA P990075S029
- Device
- MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S029
- Product code
- FWM
- Decision date
- 2014-11-26
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE WINGED INFUSION SET ACCESSORY OF THE MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT. THE MODIFICATIONS INCLUDED: 1. TEXTURE, BEVELED EDGES, AND A FINGER HOLE WAS ADDED TO EACH (2) SIDE OF THE WING DESIGN; 2. PHTHALATE WAS ELIMINATED FROM THE WING MATERIAL: PVC NAKAN FEM 828 N N WITH DEHP WITH COLORANT MASTERBATCH PVC 9154 GREEN TO PVC NAKAN FEM 828 N N WITH DEHT WITH COLORANT MASTERBATCH PVC 9154 GREEN; AND3. PHTHALATE WAS ELIMINATED FROM THE TUBING MATERIAL: PVC NAKAN FMA 748 N N WITH DEHP TO PVC NAKAN FMA 748 N N WITH DEHT.
Current openFDA PMA Record#
- Device
- MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S029
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2014-11-26
- Decision code
- APPR
- Date received
- 2014-10-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE WINGED INFUSION SET ACCESSORY OF THE MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT. THE MODIFICATIONS INCLUDED: 1. TEXTURE, BEVELED EDGES, AND A FINGER HOLE WAS ADDED TO EACH (2) SIDE OF THE WING DESIGN; 2. PHTHALATE WAS ELIMINATED FROM THE WING MATERIAL: PVC NAKAN FEM 828 N N WITH DEHP WITH COLORANT MASTERBATCH PVC 9154 GREEN TO PVC NAKAN FEM 828 N N WITH DEHT WITH COLORANT MASTERBATCH PVC 9154 GREEN; AND3. PHTHALATE WAS ELIMINATED FROM THE TUBING MATERIAL: PVC NAKAN FMA 748 N N WITH DEHP TO PVC NAKAN FMA 748 N N WITH DEHT.