PMA P990075S042
- Device
- Spectrum Saline Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S042
- Product code
- FWM
- Decision date
- 2017-08-09
- Classification
- Prosthesis, Breast, Inflatable, Internal, Saline
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Approval order statement
- Supplier change for Room Temperature Vulcanization (RTV) adhesive that is used in the assembly of Mentor® Spectrum® Saline Breast Implants with a kink valve. The current supplier location is Applied Silicone Corporation (ASC) located in Santa Paula, California. The new supplier location will be the Nusil Technology facility located in Carpinteria, California.
Current openFDA PMA Record#
- Device
- Spectrum Saline Breast Implants
- Applicant
- Mentor Worldwide, LLC
- PMA number
- P990075
- Supplement
- S042
- Product code
- FWM
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Decision date
- 2017-08-09
- Decision code
- OK30
- Date received
- 2017-07-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier change for Room Temperature Vulcanization (RTV) adhesive that is used in the assembly of Mentor® Spectrum® Saline Breast Implants with a kink valve. The current supplier location is Applied Silicone Corporation (ASC) located in Santa Paula, California. The new supplier location will be the Nusil Technology facility located in Carpinteria, California.