PMA P120011S010

Device

Ideal Implant Saline-filled Breast Implant

Applicant

Bimini Health Tech

PMA number

P120011

Supplement

S010

Product code

FWM

Decision date

2017-11-17

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).

Summary

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