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PMA P990075S043

Device
Mentor-Saline-Filled and Spectrum Breast Implants
Applicant
Mentor Worldwide, LLC
PMA number
P990075
Supplement
S043
Product code
FWM
Decision date
2017-12-06
Classification
Prosthesis, Breast, Inflatable, Internal, Saline
Generic name
Prosthesis, breast, inflatable, internal, saline
Approval order statement
Approval for changes to the labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

Current openFDA PMA Record#

Device
Mentor-Saline-Filled and Spectrum Breast Implants
Applicant
Mentor Worldwide, LLC
PMA number
P990075
Supplement
S043
Product code
FWM
Generic name
Prosthesis, breast, inflatable, internal, saline
Decision date
2017-12-06
Decision code
APPR
Date received
2017-11-06
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for changes to the labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).