FDA.reportPublic FDA data

PMA P990075S050

Device
Mentor Saline-Filled and Spectrum Breast Implants
Applicant
Mentor Worldwide, LLC
PMA number
P990075
Supplement
S050
Product code
FWM
Decision date
2021-06-04
Generic name
Prosthesis, breast, inflatable, internal, saline
Approval order statement
Changes in the primary packaging equipment used in the manufacturing process for MemoryShape, MemoryGel, and Saline-Filled andSpectrum Breast Implants.

Current openFDA PMA Record#

Device
Mentor Saline-Filled and Spectrum Breast Implants
Applicant
Mentor Worldwide, LLC
PMA number
P990075
Supplement
S050
Product code
FWM
Generic name
Prosthesis, breast, inflatable, internal, saline
Decision date
2021-06-04
Decision code
OK30
Date received
2021-05-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes in the primary packaging equipment used in the manufacturing process for MemoryShape, MemoryGel, and Saline-Filled andSpectrum Breast Implants.