FDA.reportPublic FDA data

PMA P990075S048

Device
Mentor Saline-Filled and SPECTRUM Breast Implants
Applicant
Mentor Worldwide, LLC
PMA number
P990075
Supplement
S048
Product code
FWM
Decision date
2020-10-30
Generic name
Prosthesis, breast, inflatable, internal, saline
Approval order statement
Change in manufacturing equipment and supplier location for molding components of the Dome Pack accessories that are provided with the Spectrum® Saline-Filled Breast Implants.

Current openFDA PMA Record#

Device
Mentor Saline-Filled and SPECTRUM Breast Implants
Applicant
Mentor Worldwide, LLC
PMA number
P990075
Supplement
S048
Product code
FWM
Generic name
Prosthesis, breast, inflatable, internal, saline
Decision date
2020-10-30
Decision code
OK30
Date received
2020-09-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in manufacturing equipment and supplier location for molding components of the Dome Pack accessories that are provided with the Spectrum® Saline-Filled Breast Implants.