Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor Spectrum Breast Implants, Mentor Saline-Filled Breast Implants

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas DNA Sample Preparation Kit / Roche cobas 4800 BRAF V600 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas BRAF V600 Mutation Test

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED MAMMARY PROSTHESES

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen EGFR RGQ PCR Kit

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE FILLED BREAST IMPLANTS AND SPECTRUM BREAST IMPLANTS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED BREAST IMPLANTS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas® EGFR Mutation Test, v2.0

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE FILLED BREAST IMPLANT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR MUTATION TEST v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas® EZH2 Mutation Test

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS