PMA P990074S041

Device

Natrelle Saline-Filled Breast Implants

Applicant

Allergan

PMA number

P990074

Supplement

S041

Product code

FWM

Decision date

2017-11-03

Classification

Prosthesis, Breast, Inflatable, Internal, Saline

Generic name

Prosthesis, breast, inflatable, internal, saline

Approval order statement

Implement an Electronic Data Acquisition (EDA) System to collect cycle parameter, such as temperature and time, for the shell drying after washing and gel curing after shell filling occur in the Blue-M oven. The above change is located 900 Parkway Global Park, La Aurora, Heredia, Costa Rica.

Summary

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