PMA P040046S022

Device: NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
Applicant: Allergan
PMA number: P040046
Supplement: S022
Product code: FTR
Decision date: 2017-10-13
Classification: Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-filled
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Approval order statement: Approval of a planned manufacturing capacity expansion at the Costa Rica manufacturing facility and the addition of manufacturing equipment.

Current openFDA PMA Record#

Device: NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
Applicant: Allergan
PMA number: P040046
Supplement: S022
Product code: FTR
Generic name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
Decision date: 2017-10-13
Decision code: APPR
Date received: 2017-04-13
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of a planned manufacturing capacity expansion at the Costa Rica manufacturing facility and the addition of manufacturing equipment.