PMA P020056S061

Device: Natrelle Silicone-Filled Breast Implants
Applicant: Allergan
Product code: FTR
Decision date: 2023-07-12
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Approval for including the final results from the BIFS-001 NBIR-Arm Clinical Study in the labeling documents for Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Implants.

Current openFDA PMA Record

Device: Natrelle Silicone-Filled Breast Implants
Applicant: Allergan
PMA number: P020056
Supplement: S061
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2023-07-12
Decision code: APPR
Date received: 2022-08-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for including the final results from the BIFS-001 NBIR-Arm Clinical Study in the labeling documents for Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Implants.