PMA P020056S046

Device: NATRELLE Silicon-Filled Breast Implants
Applicant: Allergan
PMA number: P020056
Supplement: S046
Product code: FTR
Decision date: 2018-06-27
Classification: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Approval to implement an additional incoming specification, i.e., verify the color of the gel material by using the Ultra Scan VIS Sensor System to confirm that the gel color does not change between shipment and receipt. There are no changes to existing incoming specification, manufacturing process, and final device specifications. The addition of this assessment is specific to the 900 Parkway Global Park, La Aurora, Heredia, Costa Rica manufacturing site.

Current openFDA PMA Record#

Device: NATRELLE Silicon-Filled Breast Implants
Applicant: Allergan
PMA number: P020056
Supplement: S046
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2018-06-27
Decision code: APPR
Date received: 2017-12-18
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to implement an additional incoming specification, i.e., verify the color of the gel material by using the Ultra Scan VIS Sensor System to confirm that the gel color does not change between shipment and receipt. There are no changes to existing incoming specification, manufacturing process, and final device specifications. The addition of this assessment is specific to the 900 Parkway Global Park, La Aurora, Heredia, Costa Rica manufacturing site.